ABSORB III Randomized Controlled Trial (RCT)
ABSORB-III
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.
1 other identifier
interventional
2,008
2 countries
192
Brief Summary
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS). The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Dec 2012
Longer than P75 for not_applicable coronary-artery-disease
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
December 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedResults Posted
Study results publicly available
February 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 11, 2023
January 1, 2021
3.8 years
December 13, 2012
August 29, 2017
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
1 year
Secondary Outcomes (35)
Number of Participants With Powered Secondary Endpoint: Angina
1 year
Number of Participants With Powered Secondary Endpoint: All Revascularization
1 year
Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
1 year
Acute Success- Device Success (Lesion Level Analysis)
On day 0 (the day of procedure)
Acute Success: Procedural Success (Subject Level Analysis)
On day 0 (the day of procedure)
- +30 more secondary outcomes
Other Outcomes (16)
Patient Reported Outcomes (PRO): Overall Health Status
Baseline
Patient Reported Outcomes (PRO): Overall Health Status
1 month
Patient Reported Outcomes (PRO): Overall Health Status
12 months
- +13 more other outcomes
Study Arms (2)
Absorb BVS
EXPERIMENTALSubjects receiving Absorb BVS
XIENCE
ACTIVE COMPARATORSubjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
Interventions
* Scaffold diameters: 2.5, 3.0 and 3.5 mm * Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. * The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). * Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm * Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition * For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Eligibility Criteria
You may qualify if:
- Subject must be at least 18 years of age.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
- Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
- Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.
- One or two de novo target lesions:
- If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
- If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
- The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
- Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and \< 100% with a TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
- Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
- Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
- For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.
You may not qualify if:
- Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
- Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
- Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
- Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
- Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
- Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
- Subject requires coumadin or any other agent for chronic oral anticoagulation.
- Subject is likely to become hemodynamically unstable due to their arrhythmia.
- Subject has poor survival prognosis due to their arrhythmia.
- Subject has a left ventricular ejection fraction (LVEF) \< 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
- Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime \>30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
- Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions \< 30 days after the index procedure
- Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
- At the time of screening, the subject has a malignancy that is not in remission.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
- +35 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (192)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
University of Alabama Hospital
Birmingham, Alabama, 35233, United States
Thomas Hospital
Fairhope, Alabama, 36532, United States
Baptist Medical Center South
Montgomery, Alabama, 36117, United States
Chandler Regional Medical Center
Gilbert, Arizona, 85297, United States
Banner Heart Hospital
Mesa, Arizona, 85206, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85260, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
John Muir Medical Center - Concord Campus
Concord, California, 94520, United States
Washington Hospital
Fremont, California, 94538, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90043, United States
Sutter Central Valley Hospitals dba Memorial Medical Center
Modesto, California, 95355, United States
Mercy General Hospital
Sacramento, California, 95816, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Sutter Medical Center
Sacramento, California, 95819, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Little Company Of Mary Hospital
Torrance, California, 90503, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
UCH-Memorial Health Systems
Colorado Springs, Colorado, 80909, United States
Medical Center of the Rockies
Fort Collins, Colorado, 80538, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06520, United States
St. Vincent's Medical Center
Stamford, Connecticut, 06905, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
Brandon Regional Hospital
Brandon, Florida, 33511, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
St. Vincent's Medical Center
Jacksonville, Florida, 32204, United States
Baptist Medical Center - Downtown
Jacksonville, Florida, 32207, United States
University of Florida UF Health
Jacksonville, Florida, 32209, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
MediQuest Research Group Inc at Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Florida Hospital
Orlando, Florida, 32803, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, 33410, United States
Bay County Health Systems
Panama City, Florida, 32401, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Tampa General Hospital
Tampa, Florida, 33609, United States
Florida Hospital Pepin Heart Institute
Tampa, Florida, 33613, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
University Hospital
Augusta, Georgia, 30901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Saint Francis Medical Center
Peoria, Illinois, 61614, United States
St. John's Hospital
Springfield, Illinois, 62701, United States
Elkhart General Healthcare
Elkhart, Indiana, 46514, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Genesis Medical Center
Davenport, Iowa, 52803, United States
Mercy Medical
West Des Moines, Iowa, 50266, United States
The University of Kansas Hospital and Medical Center
Kansas City, Kansas, 66106, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Medical Center
Portland, Maine, 04102, United States
MedStar Washington Hospital Center
Hyattsville, Maryland, 20782, United States
Union Memorial Hospital
Hyattsville, Maryland, 20782, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21804, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
St. Elizabeth's Medical Center of Boston
Brighton, Massachusetts, 02135, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Bay Regional Medical Center
Bay City, Michigan, 48708, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Sparrow Hospital
Lansing, Michigan, 48910, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
William Beaumont Hospital
Royal Oak, Michigan, 48703, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
North Mississippi Medical Center Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801, United States
Boone Hospital Center
Columbia, Missouri, 65201, United States
Mercy Hospital Springfield
Springfield, Missouri, 65807, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
St. Anthony's Medical Center
St Louis, Missouri, 63129, United States
St. Patrick Hospital
Missoula, Montana, 59802, United States
Nebraska Heart Hospital
Lincoln, Nebraska, 68526, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Cooper University Hospital
Haddon Heights, New Jersey, 08035, United States
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, 08035, United States
Morristown Medical Center
Morristown, New Jersey, 07962, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Presbyterian Hospital
Albuquerque, New Mexico, 87106, United States
St. Joseph's Hospital Health Center
Liverpool, New York, 13088, United States
Long Island Jewish Medical Center
Manhasset, New York, 11030, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York Presbyterian Hospital-Cornell University
New York, New York, 10065, United States
Lennox Hill Hospital,
New York, New York, 10075, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Strong Memorial Hospital
Rochester, New York, 14627, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27110, United States
Rex Hospital
Raleigh, North Carolina, 27607, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Aultman Hospital
Canton, Ohio, 44710, United States
University Hospital
Cincinnati, Ohio, 45206, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
EMH Healthcare
Elyria, Ohio, 44035, United States
Cleveland Cln Fairview Hospital
Fairview Park, Ohio, 44126, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Mercy St. Vincent's Medical Center
Toledo, Ohio, 43608, United States
Genesis-Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Hillcrest Medical Center
Tulsa, Oklahoma, 74104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
PeaceHealth Sacred Heart Medical Center
Springfield, Oregon, 97477, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
UPMC Hamot
Erie, Pennsylvania, 16550, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15219, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, 17043, United States
St. Joseph Medical Center
Wyomissing, Pennsylvania, 19610, United States
York Hospital
York, Pennsylvania, 17405, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204, United States
Greenville Memorial Hospital of the Greenville Health System
Greenville, South Carolina, 29605, United States
St. Francis Health System
Greenville, South Carolina, 29607, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Northwest Texas Healthcare System
Amarillo, Texas, 79106, United States
Seton Medical Center Austin
Austin, Texas, 78705, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75204, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Methodist Texsan Hospital
San Antonio, Texas, 78201, United States
East Texas Medical Center
Tyler, Texas, 75701, United States
Trinity Mother Frances Hospital Regional Healthcare Center
Tyler, Texas, 75701, United States
InterMountain Medical Center
Murray, Utah, 84107, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Mary Washington Hospital
Fredericksburg, Virginia, 22401, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
St. Joseph Hospital
Bellingham, Washington, 98225, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
St. Mary's Medical Center
Huntington, West Virginia, 25701, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Related Publications (9)
Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
PMID: 33893022DERIVEDStone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.
PMID: 31561250DERIVEDKereiakes DJ, Ellis SG, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, Tan SH, Ediebah DE, Simonton C, Stone GW; ABSORB III Investigators. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. Circulation. 2019 Dec 3;140(23):1895-1903. doi: 10.1161/CIRCULATIONAHA.119.042584. Epub 2019 Sep 25.
PMID: 31553222DERIVEDKereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol. 2017 Dec 12;70(23):2852-2862. doi: 10.1016/j.jacc.2017.10.010. Epub 2017 Oct 31.
PMID: 29100702DERIVEDAli ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.
PMID: 29089314DERIVEDBaron SJ, Lei Y, Chinnakondepalli K, Vilain K, Magnuson EA, Kereiakes DJ, Ellis SG, Stone GW, Cohen DJ; ABSORB III Investigators. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial. JACC Cardiovasc Interv. 2017 Apr 24;10(8):774-782. doi: 10.1016/j.jcin.2017.01.022.
PMID: 28427593DERIVEDStone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
PMID: 26825231DERIVEDEllis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
PMID: 26457558DERIVEDKereiakes DJ, Ellis SG, Popma JJ, Fitzgerald PJ, Samady H, Jones-McMeans J, Zhang Z, Cheong WF, Su X, Ben-Yehuda O, Stone GW. Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. Am Heart J. 2015 Oct;170(4):641-651.e3. doi: 10.1016/j.ahj.2015.07.013. Epub 2015 Jul 26.
PMID: 26386787DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Latania Chura / Project Manager
- Organization
- Abbott Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen G Ellis, MD
Cleveland Clinic, Cleveland OH
- PRINCIPAL INVESTIGATOR
Dean J Kereiakes, MD
The Christ Hospital, Cincinnati, OH
- STUDY CHAIR
Gregg W Stone, MD
Columbia University Medical Center, New York, NY
- STUDY DIRECTOR
Jennifer McMeans Jones
Abbott Medical Devices
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2012
First Posted
December 18, 2012
Study Start
December 1, 2012
Primary Completion
September 1, 2016
Study Completion
October 1, 2020
Last Updated
October 11, 2023
Results First Posted
February 13, 2018
Record last verified: 2021-01