SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
1 other identifier
interventional
1,002
1 country
65
Brief Summary
This study is divided into 5 arms:
- 1.Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
- 2.US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
- 3.US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
- 4.US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
- 5.Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
Longer than P75 for phase_3
65 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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedResults Posted
Study results publicly available
December 15, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 23, 2011
November 1, 2011
1.5 years
September 13, 2005
October 15, 2008
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoint: In-segment Late Loss (LL)
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
240 days
Secondary Outcomes (43)
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
270 days
Target Vessel Failure (TVF)
30 days
Target Vessel Failure (TVF)
180 days
Target Vessel Failure (TVF)
1 year
Target Vessel Failure (TVF)
2 year
- +38 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALXIENCE V® Everolimus Eluting Coronary Stent System
2
ACTIVE COMPARATORTAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System
Interventions
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Eligibility Criteria
You may qualify if:
- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between \>= 2.25 mm and \<= 4.25 mm and a lesion length \<= 32 mm
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of \>= 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of \>= 1
- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done \>= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)
You may not qualify if:
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation \>= 2 mm in diameter or ostial lesion \> 50% stenosed by visual estimation or side branch requiring predilatation
- Located in a major epicardial vessel that has been previously treated with brachytherapy
- Located in a major epicardial vessel that has been previously treated with percutaneous intervention \< 9 months prior to index procedure
- Total occlusion (TIMI flow 0), prior to wire passing
- The target vessel contains thrombus
- Another significant lesion (\> 40% diameter stenosis \[DS\]) is located in the same epicardial vessel as the target lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
Baptist Health System - Montclair
Birmingham, Alabama, 35213, United States
Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
Good Samaritan Hospital
Los Angeles, California, 87106, United States
Alta Bates Summit Medical Center
Oakland, California, 94609, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80528, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Holy Cross Medical Center (prev. North Ridge MC)
Fort Lauderdale, Florida, 33308, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60148, United States
St. John's Hospital
Springfield, Illinois, 62701, United States
The Heart Center of IN, LLC
Indianapolis, Indiana, 46290, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
St John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Spectrum Health Hospital
Grand Rapids, Michigan, 49503, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, 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
Hackensack Medical Center
Hackensack, New Jersey, 07601, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Presbyterian Hospital
Albuquerque, New Mexico, 28204, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Columbia University Medical Center
New York, New York, 10032, United States
St. Joseph's Hospital Health Center
Syracuse, New York, 13203, United States
Presbyterian Hospital
Charlotte, North Carolina, 87106, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
EMH Regional Medical Center
Elyria, Ohio, 44035, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Integris Baptist Medical, Inc.
Oklahoma City, Oklahoma, 73112, United States
Sacred Heart Medical Center
Eugene, Oregon, 97401, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Pinnacle Health @ Harrisburg Hospital
Harrisburg, Pennsylvania, 17043, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Methodist Hospital
Houston, Texas, 77030, United States
TexSan Heart Hospital
San Antonio, Texas, 78215, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (9)
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
PMID: 18430909RESULTStone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. doi: 10.1161/CIRCULATIONAHA.108.803528. Epub 2009 Jan 26.
PMID: 19171853RESULTLansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):719-27. doi: 10.1002/ccd.22067.
PMID: 19530147RESULTGenereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
PMID: 25940520DERIVEDMuramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
PMID: 24746650DERIVEDClaessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016.
PMID: 22115661DERIVEDPlaner D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.
PMID: 22017936DERIVEDKereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39. doi: 10.1016/j.jcin.2010.09.014.
PMID: 21232716DERIVEDCaixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8. doi: 10.1016/j.jcin.2010.07.017.
PMID: 21232715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ellen Travis, Clinical Science
- Organization
- Abbott Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
Gregg W Stone, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
June 1, 2005
Primary Completion
December 1, 2006
Study Completion
November 1, 2011
Last Updated
November 23, 2011
Results First Posted
December 15, 2008
Record last verified: 2011-11