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| Sponsored by: |
Boston Scientific Corporation |
|---|---|
| Information provided by: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00484315 |
Purpose
The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28mm in length in native coronary arteries of 2.75mm to 4.0mm diameter.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: PCI with drug-eluting stent implantation Device: PCI with drug eluting stent placement Device: PCI with TAXUS Express 2 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions |
| Estimated Enrollment: | 1264 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| TAXUS Element: Experimental |
Device: PCI with drug-eluting stent implantation
TAXUS Element stent placement
|
| TAXUS Express 2: Active Comparator |
Device: PCI with drug eluting stent placement
TAXUS Express 2 Stent Implant
Device: PCI with TAXUS Express 2
Stent implantation with TAXUS Express 2
|
This is a prospective, 3:1 randomization, multi-center trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of up to 28mm in length in native coronary arteries ≥ 2.75mm and ≤ 4.0mm in diameter, compared to a control group of TAXUS Express2 stents.
One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS).
Eligible subjects will have annual follow-up until 5 years post-index procedure.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Clinical Inclusion Criteria:
Key Angiographic Inclusion Criteria:
•Target Lesion
Key Clinical Exclusion Criteria:
Contacts and Locations
Show 94 Study Locations| Principal Investigator: | Dean J Kereiakes, MD | The Christ Hospital |
| Principal Investigator: | Louis A Cannon, MD | Cardiac and Vascular Research Center of Northern Michigan |
More Information
| Responsible Party: | Boston Scientific ( Amy Britt ) |
| Study ID Numbers: | S2037, S2037-PIVOT-2006 |
| Study First Received: | June 6, 2007 |
| Last Updated: | October 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00484315 |
| Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe; Singapore: Health Sciences Authority |
|
drug-eluting stent DES |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
|
Cardiovascular Diseases |
