A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
- Conditions
- In-Stent Restenosis
- Registration Number
- NCT06492174
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Clinical Inclusion Criteria:<br><br> - Subject must be at least 18 years of age<br><br> - Subject (or legal guardian) understands the trial requirements and the treatment<br> procedures, and provides written informed consent before any trial-specific tests or<br> procedures are performed<br><br> - Subject is eligible for percutaneous coronary intervention (PCI)<br><br> - Subject is willing to comply with all protocol-required follow-up evaluation<br><br> - Women of child-bearing potential must agree to use a reliable method of<br> contraception from the time of screening through 12 months after the index procedure<br><br>Angiographic Inclusion Criteria (visual estimate)<br><br> - In-stent restenosis in a lesion previously treated with either a drug-eluting stent<br> or bare metal stent, located in a native coronary artery with a visually estimated<br> reference vessel diameter (RVD) > 2.0 mm and = 4.0 mm.<br><br> - Target lesion length must be = 36 mm (by visual estimate) and must be covered by<br> only one balloon.<br><br> - Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic<br> patients (>70% and <100% in asymptomatic patients) prior to lesion pre-dilation.<br><br> - Target lesion must be successfully pre-dilated.<br><br>Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of<br>appropriate length and diameter, or pretreatment with directional or rotational coronary<br>atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis<br>and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.<br>Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be >2<br><br> - If a non-target lesion is treated, it must be treated first and must be deemed a<br> success.<br><br>Note: Successful treatment of a non-target lesion is defined as a residual stenosis of =<br>30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the<br>physician, without the occurrence of prolonged chest pain or ECG changes consistent with<br>MI.<br><br>Clinical Exclusion Criteria:<br><br> - Subject has other serious medical illness (e.g. cancer, congestive heart failure)<br> that may reduce life expectancy to less than 24 months.<br><br> - Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin,<br> etc.).<br><br> - Subject has planned procedure that may cause non-compliance with the protocol or<br> confound data interpretation.<br><br> - Subject is participating in another investigational drug or device clinical study<br> that has not reached its primary endpoint.<br><br> - Subject intends to participate in another investigational drug or device clinical<br> study within 12 months after the index procedure.<br><br> - Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days<br> prior to the index procedure, except for women who definitely do not have<br> child-bearing potential.)<br><br> - Left ventricular ejection fraction known to be < 25%.<br><br> - Subject had PCI or other coronary interventions within the last 30 days.<br><br> - Planned PCI or CABG after the index procedure.<br><br> - STEMI or QWMI <72h prior to the index procedure.<br><br> - Cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support).<br><br> - Known allergies against paclitaxel or other components of the used medical devices.<br><br> - Known hypersensitivity or contraindication for contrast dye that in the opinion of<br> the investigator cannot be adequately pre- medicated.<br><br> - Intolerance to antiplatelet drugs, anticoagulants required for procedure.<br><br> - Platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3.<br><br> - Subject with renal insufficiency (creatinine =2.0 mg/dl) or failure (dialysis<br> dependent).<br><br> - Subject has suspected or proven COVID-19 at present or within the past 4 weeks with<br> resolution of symptoms.<br><br>Angiographic Exclusion Criteria (visual estimate)<br><br> - Target lesion is located within a bifurcation with planned treatment of side branch<br> vessel.<br><br> - Target lesion is located within a saphenous vein or arterial graft.<br><br> - Thrombus present in the target vessel<br><br> - > 50% stenosis of an additional lesion proximal or clinically significant distal<br> (>2.0mm RVD) to the target lesion.<br><br> - Patient with unprotected left main coronary artery disease. (>50% diameter stenosis)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Target Lesion Failure
- Secondary Outcome Measures
Name Time Method