SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
NCT ID: NCT00307047
Last Updated: 2012-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3687 participants
INTERVENTIONAL
2006-08-31
2012-05-31
Brief Summary
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TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.
Detailed Description
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The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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XIENCE V®
XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
TAXUS™ EXPRESS2™
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Interventions
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XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
* Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
* Subject must agree to undergo all protocol-required follow-up procedures
* Subject must agree not to participate in any other clinical study for a period of one year following the index procedure
* Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)
* Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)
* If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
* If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
* The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1
* Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure
* Non-study percutaneous intervention for lesions in a non-target vessel involving:
* Successful and uncomplicated (visually estimated diameter stenosis \< 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be \< 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted
* Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure
* Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure
* Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure
Exclusion Criteria
* The subject is currently experiencing clinical symptoms consistent with AMI
* Subject has current unstable arrhythmias
* Subject has a known left ventricular ejection fraction (LVEF) \< 30%
* Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
* Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
* Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
* Subject has known renal insufficiency (e.g., serum creatinine level of \> 2.5 mg/dL or subject on dialysis)
* Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
* Subject has had a significant GI or urinary bleed within the past six months
* Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
* Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year
* Subject is already participating in another clinical study that has not yet reached its primary endpoint
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)
* The target lesion(s) meets any of the following criteria:
* Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)
* Located within 2 mm of the origin of the LAD or LCX
* Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis \> 20%) arterial or saphenous vein graft
* Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is \> 50% stenosed by visual estimation
* Involves a side branch requiring pre-dilatation
* Total occlusion (TIMI flow 0) prior to wire crossing
* Excessive tortuosity proximal to or within the lesion
* Extreme angulation (≥ 90º) proximal to or within the lesion
* Heavy calcification
* Restenotic from previous intervention
* Subject has received brachytherapy in any epicardial vessel (including side branches)
* The target vessel contains thrombus
* Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure
* Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg W Stone
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Scottsdale Healthcare
Scottsdale, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Inova Fairfax Hospital
Fairfax, California, United States
San Diego Cardiovascular Associates
La Jolla, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Good Samaritan Hospital - LA
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
Sutter Medical Center of Santa Rosa
Santa Rosa, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
St. Francis Hospital and Health Centers
Indianapolis, Indiana, United States
The Heart Center of Indiana
Indianapolis, Indiana, United States
Iowa Heart Center P.C.
Des Moines, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Jewish Hospital
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
St. Joseph Medical Center
Towson, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Saint Vincent Hospital
Worcester, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Bay Regional Medical Center
Bay City, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Spectrum Health Hospital
Grand Rapids, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Ingham Regional Medical Center
Lansing, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
St. Patrick Hospital
Missoula, Montana, United States
Nebraska Heart Hospital
Lincoln, Nebraska, United States
Dartmouth Hitchock Medical Center
Lebanon, New Hampshire, United States
Millard Fillmore Hospital
Buffalo, New York, United States
New York Presbyterian Hospital-Cornell
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
The Valley Hospital
Pomona, New York, United States
Stony Brook Hospital and Medical Center
Stony Brook, New York, United States
St. Joseph's Hospital Health Center
Syracuse, New York, United States
Presbyterian Hospital - Charlotte
Charlotte, North Carolina, United States
Pitt County Memorial Hospital
Greenville, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
EMH Regional Medical Center
Elyria, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Sisters of Charity Providence Hospitals
Columbia, South Carolina, United States
St. Francis Health System
Greenville, South Carolina, United States
Vanderbilt Vniversity Medical Center
Nashville, Tennessee, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Sentara Norfolk General
Norfolk, Virginia, United States
St. Luke's Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
Countries
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References
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Genereux 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.
Muramatsu 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.
Pervaiz MH, Sood P, Sudhir K, Hermiller JB, Hou L, Hattori K, Su X, Cao S, Wang J, Applegate RJ, Kereiakes DJ, Yaqub M, Stone GW, Cutlip DE. Periprocedural myocardial infarction in a randomized trial of everolimus-eluting and Paclitaxel-eluting coronary stents: frequency and impact on mortality according to historic versus universal definitions. Circ Cardiovasc Interv. 2012 Apr;5(2):150-6. doi: 10.1161/CIRCINTERVENTIONS.111.965566. Epub 2012 Mar 20.
Claessen 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.
Planer 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.
Kereiakes 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.
Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.
Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
Nikolsky E, Lansky AJ, Sudhir K, Doostzadeh J, Cutlip DE, Piana R, Su X, White R, Simonton CA, Stone GW. SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. Am Heart J. 2009 Oct;158(4):520-526.e2. doi: 10.1016/j.ahj.2009.07.025. Epub 2009 Aug 26.
Other Identifiers
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05-368
Identifier Type: -
Identifier Source: org_study_id