DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.

Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.

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.