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Sponsored by: |
Abbott Vascular |
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Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00307047 |
Prospective, randomized, active-controlled, single-blinded, multicenter, US clinical trial evaluating the investigational device XIENCE™ V in subjects with reference vessel diameters (RVD) 2.5 mm to 4.25 mm and lesion lengths <= 28 mm; non-inferiority to FDA-approved commercially available TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System (TAXUS™). (NOTE: RVD 2.5 mm to 3.75 mm until 4.0 mm TAXUS™ is commercially available)
CAUTION: XIENCE™ V Everolimus Eluting Coronary Stent System is an investigational device, Limited by Federal (U.S.) law to investigational use only.
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: XIENCE™ V Everolimus Eluting Coronary Stent Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions |
Estimated Enrollment: | 3690 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
XIENCE™ V
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Device: XIENCE™ V Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
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2: Active Comparator
TAXUS™
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Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
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The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE™ V Everolimus Eluting Coronary Stent System (XIENCE™ V EECSS). The XIENCE™ V EECS (XIENCE™ V group) will be compared to an active control represented by FDA-approved commercially available Boston Scientific TAXUS™ EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS™ EXPRESS2™ PECS) System (TAXUS™ group).
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 EECS: TAXUS™ EXPRESS2™ PECS). 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, 3, 4, and 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Gregg W Stone | Columbia University Medical Center |
Responsible Party: | Abbott Vascular ( Barbara Nishimoto ) |
Study ID Numbers: | 05-368 |
Study First Received: | March 23, 2006 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00307047 |
Health Authority: | United States: Food and Drug Administration |
Stents Angioplasty Total coronary occlusion coronary restenosis stent thrombosis |
Arterial Occlusive Diseases Everolimus Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis |
Coronary Restenosis Thrombosis Coronary Disease Coronary Occlusion Paclitaxel Coronary Artery Disease |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Mitosis Modulators |
Tubulin Modulators Cardiovascular Diseases Antimitotic Agents Immunosuppressive Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |