Absorb IV Randomized Controlled Trial
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
2,604
5 countries
120
Brief Summary
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. 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. The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.
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 Jul 2014
Longer than P75 for not_applicable coronary-artery-disease
120 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
First Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedResults Posted
Study results publicly available
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2022
CompletedOctober 30, 2023
October 1, 2023
7.8 years
June 9, 2014
April 20, 2018
October 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Target Lesion Failure (TLF)
Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))
30 days
Secondary Outcomes (168)
TLF at 1-year, Non-inferiority Against the Control
1 year
Angina at 1-year, Non-inferiority Against the Control
1 year
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
In-hospital (≤ 7days)
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
In-hospital (≤ 7days)
Number of Death (Cardiac, Vascular, Non-cardiovascular)
In-hospital (≤ 7 days post index procedure)
- +163 more secondary outcomes
Study Arms (2)
Absorb BVS
EXPERIMENTALSubjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
XIENCE
ACTIVE COMPARATORSubjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)
Interventions
* Scaffold diameters: 2.5, 3.0 and 3.5 mm * Scaffold lengths: 8, 12, 18, and 28 mm. 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. * Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm. * 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. The 3.25 mm is only available for XIENCE Xpedition * Stent lengths: 8, 12, 15, 18, 23, and 28 mm * 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., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
- Unstable angina or NSTEMI within 2 weeks of the index procedure.
- STEMI \> 72 hours ≤ 2 weeks prior to the index procedure.
- Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring \> 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.
- Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).
- (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)
- 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 at least 1 year following the index procedure.
- Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.
- Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.
- If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.
- \. 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 thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI \>72 hours but ≤ 2 weeks prior to the index procedure).
- +4 more criteria
You may not qualify if:
- Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor 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 any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
- Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
- Subject has a cardiac arrhythmia 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 acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure 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 a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
- Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular 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.
- Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
John Muir Health Concord
Concord, California, 94520, United States
Washington Hospital
Fremont, California, 94538, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Univ Of California Davis Med Ctr
Sacramento, California, 95817, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Little Company Of Mary Hospital
Torrance, California, 90503, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
St. John's Hospital
Springfield, Illinois, 62769, United States
Elkhart General Hospital
Elkhart, Indiana, 46514, United States
Franciscan St Francis Health
Indianapolis, Indiana, 46237, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University Of Kentucky Hospital
Lexington, Kentucky, 40506, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48197, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
St John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, 65201, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
St. Patrick Hospital
Missoula, Montana, 59802, United States
Nebraska Heart Institute Heart Hosp.
Lincoln, Nebraska, 68526, United States
CHI Health Bergan Mercy
Omaha, Nebraska, 68124, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
NewYork-Presbyterian/Queens
Flushing, New York, 11355, United States
NYP Weill Cornell Medical Center
New York, New York, 10021, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
St. Joseph's Hospital Health Center
Syracuse, New York, 13203, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center-Northeast
Charlotte, North Carolina, 28203, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Novant Health Heart & Vascular Institute/Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Carolinas Medical Center-Pineville
Charlotte, North Carolina, 28210, United States
Rex Hospital, Inc.
Raleigh, North Carolina, 27607, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
Aultman Hospital
Canton, Ohio, 44710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Genesis Hospital
Zanesville, Ohio, 43701, United States
Integris Baptist Medical Center, Inc.
Oklahoma City, Oklahoma, 73112, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, 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
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Upmc Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
St. Joseph Medical Center
Reading, Pennsylvania, 19605, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Anmed Health Medical Center
Anderson, South Carolina, 29621, United States
Providence Hospital
Columbia, South Carolina, 29204, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Northwest Texas Healthcare System
Amarillo, Texas, 79106, United States
Seton Medical Center
Austin, Texas, 78705, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
East Texas Medical Center
Tyler, Texas, 75701, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
Providence Reg Med Ctr Everett
Everett, Washington, 98201, United States
Medstar Health Research Institute/ Medstar Washington Hospital Center
Northwest, Washington, 20010, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
The Prince Charles Hospital
Brisbane, Queensland, 4032, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital
Perth, Western Australia, 6001, Australia
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
CHUM-Hotel Dieu
Montreal, Quebec, Canada
Universitatsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Kliniken Oberallgau gGmbH
Immenstadt im Allgäu, Bavaria, 87509, Germany
Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH
Kempten (Allgäu), Bavaria, 87439, Germany
University Giessen
Giessen, Hesse, 35392, Germany
Klinikum Oldenburg
Oldenburg, Lower Saxony, 26133, Germany
Universitatsklinikum Bonn
Bonn, North Rhine-Westphalia, 53105, Germany
Elisabeth-Krankenhaus
Essen, North Rhine-Westphalia, 45138, Germany
Johannes Gutenberg-Universitaet
Mainz, Rhineland-Palatinate, 55131, Germany
Segeberger Kliniken GmbH - Herzzentrum
Bad Segeberg, Schleswig-Holstein, 23795, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, State of Berlin, 16321, Germany
National Heart Centre, Singapore, Pte, Ltd.
Singapore, 169609, Singapore
Related Publications (3)
Power DA, Camaj A, Kereiakes DJ, Ellis SG, Gao R, Kimura T, Ali ZA, Stockelman KA, Dressler O, Onuma Y, Serruys PW, Stone GW; ABSORB Investigators. Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program. JACC Cardiovasc Interv. 2025 Jan 13;18(1):1-11. doi: 10.1016/j.jcin.2024.08.050.
PMID: 39814482DERIVEDStone GW, Kereiakes DJ, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Kabour A, Piegari G, Cavendish J, Bertolet B, Stockelman KA, West NEJ, Ben-Yehuda O, Choi JW, Marx SO, Spertus JA, Ellis SG; ABSORB IV Investigators. 5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique. J Am Coll Cardiol. 2023 Jul 18;82(3):183-195. doi: 10.1016/j.jacc.2023.05.003. Epub 2023 May 17.
PMID: 37207924DERIVEDStone GW, Ellis SG, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Williams J Jr, Lawson W, Broderick TM, Kabour A, Piegari G, Cavendish J, Bertolet B, Choi JW, Marx SO, Genereux P, Kereiakes DJ; ABSORB IV Investigators. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet. 2018 Oct 27;392(10157):1530-1540. doi: 10.1016/S0140-6736(18)32283-9. Epub 2018 Sep 25.
PMID: 30266412DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kelly A. Stockelman, PhD
- Organization
- Abbott Vascular
Study Officials
- STUDY CHAIR
Gregg W Stone, MD
Columbia University Medical Center, New York, NY
- PRINCIPAL INVESTIGATOR
Gregg W Stone, MD
Columbia University Medical Center, New York, NY
- PRINCIPAL INVESTIGATOR
Stephen G Ellis, MD
Cleveland Clinic, Cleveland OH
- PRINCIPAL INVESTIGATOR
Dean J Kereiakes, MD
The Christ Hospital, Cincinnati, OH
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
June 9, 2014
First Posted
June 25, 2014
Study Start
July 1, 2014
Primary Completion
April 6, 2022
Study Completion
April 6, 2022
Last Updated
October 30, 2023
Results First Posted
July 24, 2018
Record last verified: 2023-10