A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis within Bare-Metal Stents
Phase 2
Completed
- Conditions
- restenotic lesions - stenosis10011082
- Registration Number
- NL-OMON33458
- Lead Sponsor
- utonix
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Target lesions is in a native coronary with previous single bare metal stent
Stenosis is >50% and <100% by visual estimate or QCA prior to defined pre-dilatation
Exclusion Criteria
History of MI or thrombolysis within 72 hours of randomization
History of previous target vessel perforation
Angiographic evidence of thrombus or dissection within the target vessel
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percent (%) Diameter Stenosis (DS) in the Analysis Segment at 6 months</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical (at 1, 6, 12 & 24 months)<br /><br><br /><br>- Ischemia-driven target vessel revascularization (ID-TVR) defined as targe<br /><br>vessel diameter of at least 50% by Quantitative Coronary Analysis (QCA) with<br /><br>either ECG changes at rest or a positive functional study in the distribution<br /><br>of the target vessel, or stenosis of at least 70% irrespective of symptoms.<br /><br>- Ischemia-driven target lesion revascularization (ID-TLR)<br /><br>- Composite of cardiac death, myocardial infarction, and ID-TLR<br /><br>- Composite of cardiac death, myocardial infarction and target vessel<br /><br>revascularization TVR<br /><br>- Procedural success<br /><br>- Device success</p><br>