Diabetes Mellitus Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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