Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Ka… (NCT02939924) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
Belgium, Germany50 participantsStarted 2017-04-07
Plain-language summary
Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery;
✓. Able and willing to provide informed consent prior to study procedures;
✓. Able and willing to comply with follow-up requirements;
✓. Rutherford Clinical Category of 2-4;
✓. Resting ABI of \<0.9 or abnormal exercise ABI;
✓. ≥18 years old;
✓. Life expectancy is \>2 year;
✓. Cumulative lesion length ≥4 and ≤15 cm within the target vessel; Cumulative lesion consists of either a single de novo lesion or multiple lesions within the 4-15 cm segment; multiple lesions require to meet all the following;
Exclusion criteria
✕. Pregnant or lactating females;
✕. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries;
✕. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
✕. Known intolerance to study medications, paclitaxel or contrast agents;
✕. Patient participating in another investigational device or drug study that has not reached the primary endpoint;
What they're measuring
1
The primary outcome measure of the study is a composite of freedom from device and procedure related deaths through 30 days, freedom from target limb amputation, and clinically driven target lesion revascularization (TLR) through 6 months.
✕. History of hemorrhagic stroke within 2 months;
✕. Previous or planned surgical or interventional procedure within 30 days of the study procedure;
✕. Diagnosed liver failure, renal failure, chronic kidney disease, unstable angina pectoris, or myocardial infarction within 30 days of the procedure;