DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis (DELTA)
Femoral Artery Stenosis, Popliteal Artery Stenosis
About this trial
This is an interventional treatment trial for Femoral Artery Stenosis focused on measuring PTA Scoring Balloon, Optimal Balloon Angioplasty
Eligibility Criteria
Inclusion Criteria: 18-80 year-old male & non-pregnant female Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery. Rutherford clinical category-Becker class: 2 to 5 Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study. Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3. Exclusion Criteria: Acute or sub-acute thrombosis exist in target lesion Severe calcified lesion (PACSS Grading 4) Guidewire cannot cross target lesion Amputation planned within 30 days In-stent restenosis Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment. Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique. Patient who cannot accept anticoagulant or antiplatelet therapy Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics Patients who have not completed clinical trials of other drugs or devices Patients with poor compliance and unable to complete the study, which is identified by investigator.
Sites / Locations
- The First Affiliated Hospital of Jinan University
- The First Affiliated Hospital of Harbin Medical University
- The First Affiliated Hospital of Zhengzhou University
- Xiangya Hospital of Central South University
- Suzhou Municipal Hospital
- The Affiliated Hospital of Qingdao University
- Hospital of Chengdu Traditional Chinese Medicine University
- The Third People's Hospital of Chengdu
- The Affiliated Hospital of Southwest Medical University
- China-Japan Friendship Hospital
- Xuanwu Hospital of Capital Medical University
- The First Affiliated Hospital of Naval Medical University
- Zhongshan Hospital of Fudan UniversityRecruiting
- Tianjin Medical University General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DKutting
Chocolate
DKutting LL Scoring Balloon, DK Medtech Co Ltd
Chocolate Balloon, TriReme Medical LLC