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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Femoral Artery Stenosis, Popliteal Artery Stenosis

Intervention / Treatment
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* Device: DKutting LL balloon
* Device: Chocolate balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DKutting<br>DKutting LL Scoring Balloon, DK Medtech Co Ltd | Device: DKutting LL balloon<br>* After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment<br>|
| Active Comparator: Chocolate<br>Chocolate Balloon, TriReme Medical LLC | Device: Chocolate balloon<br>* After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Optimal PTA in Percent | Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-100%, higher the better] | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success Rate in Percent | Device Success defined as successful delivery to the target lesion, deployment without balloon rupture, and retrieval after procedure, as qualitatively accessed by physician. [0-100%, higher the better] | 1 day | 
| Numerical Acute Lumen Gain in mm | In-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD, as accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-3mm, higher the better] | 1 day | 
| Technical Success Rate in percent | Percentage of target Lesion achieved <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F) and No Adverse Event happened in hospital. [0-100%, higher the better] | 0-7 days | 
| Freedom from clinical-driven TLR rate in percent | Freedom from clinical-driven target lesion revascularization 1 month post procedure [0-100%, higher the better] | 30+/-7 Days post procedure | 
| Rutherford Grading Reduction in percent | Percentage of both groups' patent number, whose Rutherford Grading [0-6, lower is reduced by at least 1 grade post procedure, compared with pre-procedure grade. [0-100%, higher the better] | 30+/-7 Days post procedure | 
| Freedom from Amputation above ankle rate in percent | Percentage of both groups' patient number who is free from Amputation above ankle 1 month post procedure. [0-100%, higher the better] | 30+/-7 Days post procedure | 
| Numerical Ankle Brachial Index | Record of both groups' patient's Ankle Brachial Index (ABI) pre/post procedure by Doppler ultrasonic stethoscope. [ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people] | 0-7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTA Scoring Balloon, Optimal Balloon Angioplasty