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NCT00307047 · ClinicalTrials.gov registry record · Phase 3
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
A Phase 3 study of Coronary Artery Disease, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,687
- Enrollment target
- 20
- Study locations
NCT00307047: Completed Phase 3 study of Coronary Artery Disease, sponsored by Abbott Medical Devices.
NCT00307047 is a Phase 3 study of Coronary Artery Disease that has completed, run by Abbott Medical Devices. The registered enrollment target is 3,687 participants, above the 1,270-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (190% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00307047, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,687 participants
- Enrollment target
- 20
- Study locations
Study Summary
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®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific. TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.
Primary Outcome
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Conditions Studied
Interventions
- DEVICE XIENCE V® Everolimus Eluting Coronary Stent
- DEVICE TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Study Locations (20)
California
- Inova Fairfax Hospital - Fairfax
- San Diego Cardiovascular Associates - La Jolla
- Scripps Memorial Hospital - La Jolla
- Good Samaritan Hospital - LA - Los Angeles
- Mercy General Hospital - Sacramento
- Sutter Medical Center of Santa Rosa - Santa Rosa
Colorado
- The Medical Center of Aurora - Aurora
- Poudre Valley Hospital - Fort Collins
Florida
- Sacred Heart Hospital - Pensacola
- Sarasota Memorial Hospital - Sarasota
Indiana
- St. Francis Hospital and Health Centers - Indianapolis
- The Heart Center of Indiana - Indianapolis
Kentucky
- Central Baptist Hospital - Lexington
- Jewish Hospital - Louisville
Arizona
- Scottsdale Healthcare - Scottsdale
Arkansas
- Arkansas Heart Hospital - Little Rock
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,687 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00307047 record still lists
NCT00307047 is an interventional study that assigns participants to a tested intervention. Its 3,687 participants enrollment target places it among the larger protocols in the corpus, above the 1,270-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (190% higher).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which XIENCE V® Everolimus Eluting Coronary Stent is the first listed.
NCT00307047 names 20 study sites across 11 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT00307047 about?
NCT00307047 is a clinical study titled "SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System". 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®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary ...
What is the current status of trial NCT00307047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,687 participants. The study started on 2006-08. Estimated completion is 2012-05.
What conditions does trial NCT00307047 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT00307047?
The interventions under investigation include: XIENCE V® Everolimus Eluting Coronary Stent (DEVICE), TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent (DEVICE).
Who is sponsoring clinical trial NCT00307047?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00307047 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00307047's enrollment target sits among peer trials
3,687 20th of 219 higher than 200 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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