AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.

Detailed Description
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PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia. DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Official Title
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Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Procedure: DEB catheter
* Procedure: common PTA balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 85 years Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6 an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery The expected survival time is more than 1 year signed Patient informed consent form Exclusion Criteria: Serum creatinine clearance rate less than 30ml/min in patients patients with acute thrombosis requiring lysis or thrombectomy patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks patient requiring intervention in both lower limbs at the same time In-stent restenosis in the blow-knee popliteal artery target lesion can't be cross by the guide wire the stenosis rate of proximal outflow more than 30% with or without intervention the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention stenosis or occlusion of distal outflow for below-the-ankle artery. expected major amputations at the index limb before intervention known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. patients participating in another clinical trials with interfere with this trial in the same time pregnancy and lactating woman untreatable bleeding diatheses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: DEB catheter<br>use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm | Procedure: DEB catheter<br>* DEB catheter (trade name: Litos/Tulip)<br>|
| Active Comparator: common PTA balloon catheter<br>use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group | Procedure: common PTA balloon catheter<br>* common PTA balloon catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency [Time Frame: 6 months] | Freedom from target vessel occlusion and clinically driven target lesion reintervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device success rate | DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully. | during the operation(after using the DEB catheter) | 
| technical success rates | The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50% | during the operation(after using the DEB catheter) | 
| operation success rate | both device succeed and technical succeed, and without clinical complication | during the operation(after using the DEB catheter) | 
| if occured clinically driven TLR( target lesion revascularization) | Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers | 6 months, 12 months,18 months, 24 months | 
| target lesion late lumen loss 6 months | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months | 6 months | 
| Ulcer healing rate | Healed or not, if not, improving,stagnant, worsening | 6 months, 12 months | 
| Ulcer healing time | Healed or not | 6 months, 12 months, 18 months, 24 months | 
| Change from baseline ankle brachial index(ABI) at 6 months | measure ankle brachial index >1.3 Vascular wall calcification is severe 0.9 1.1 Normal range 0.5 0.8 Mild and moderate ischemia of lower limb arteries <0.5 severe ischemia | 6 months | 
| change from baseline Rutherford stage at 6 months | based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic mild claudication moderate claudication severe claudication ischemic rest pain minor tissue loss ulceration or gangrene | 6 months, 12 months,18 months, 24 months | 
| limb salvage in surviving subjects | No Amputation of target limb | 30 days, 6 months, 12 months,18 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon catheter