Trials / Completed
CompletedNCT00462631
Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic Patients
Paclitaxel-Eluting Balloon Angioplasty and Cobalt-Chromium Stents Versus Conventional Angioplasty and Paclitaxel-Eluting Stents in the Treatment of Native Coronary Artery Stenoses of Diabetic Patients
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Heart Centre Rotenburg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural success and preservation of vessel patency. This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Malaysia and Thailand. 128 diabetes mellitus patients shall complete the study per protocol after random assignment to either of the treatment groups on the order of 20 to 50 patients per center. Diabetes mellitus patients with stable or selected forms of unstable angina or documented ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may not supply an entirely infarcted myocardial area. Late lumen loss at 9 months is the primary endpoint.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paclitaxel Eluting Balloon | Paclitaxel eluting balloon |
| DEVICE | paclitaxel eluting stent | paclitaxel eluting stent |
| DEVICE | bare metal stent | bare metal stent |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2011-09-01
- Completion
- 2016-02-01
- First posted
- 2007-04-19
- Last updated
- 2016-02-19
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT00462631. Inclusion in this directory is not an endorsement.