A Multicenter Randomized Comparison of Paclitaxel-eluting Balloon Catheter with Conventional Balloon Angioplasty in Patients with Bare-metal Stent Restenosis and Drug-eluting Stent Restenosis
- Conditions
- Ischemic heart disease
- Registration Number
- JPRN-UMIN000008681
- Lead Sponsor
- ipro Corporation (Osaka, Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 210
Not provided
The lesion containing proximal or distal tortuosity with more than 90-degree angle; multiple lesions in the target vessel; total coronary artery occlusion; heavily calcified lesion; lesion in bypass graft; or bifurcation lesion with side branch of larger than 2.0 mm in diameter was not regarded as the target lesion. Clinical exclusion criteria were as follows: left ventricular ejection fraction of less than 30%; myocardial infarction within 72 hr before enrollment; intolerance to antiplatelet or anticoagulant drugs, drugs similar to paclitaxel and contrast media; acute or chronic renal dysfunction with serum creatinine level of not less than 1.5 mg/dL; patients with severe concomitant systemic illness whom the treating physician considered it better to exclude; any coronary intervention procedure within previous 28 days; patients with cerebral infarction, transient cerebral ischemic attack or hemorrhagic gastric ulcer within previous 6 months; women who were pregnant or of childbearing potential; patients with implantation of DES within previous 6months; and patients with left main disease (LMT>50% diameter stenosis).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method target vessel failure (TVF) at 6-month follow-up
- Secondary Outcome Measures
Name Time Method lesion success (attainment of less than 50% in-stent residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis), and procedure success (attainment of a final lesion success and no in-hospital major adverse cardiac events). Secondary angiographic endpoints were in-stent binary restenosis rate and late lumen loss. Secondary clinical endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, myocardial infarction, death, and major adverse cardiac events.