|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Medtronic Vascular |
|---|---|
| Information provided by (Responsible Party): | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT00248079 |
Purpose
To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Coronary Artery Stenting |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions |
| Enrollment: | 139 |
| Study Start Date: | November 2005 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT00248079 History of Changes |
| Other Study ID Numbers: | IP069 |
| Study First Received: | November 1, 2005 |
| Last Updated: | October 18, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Health Research Council |
|
Coronary Disease |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |