Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions

Study Overview
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Brief Summary
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The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.

Detailed Description
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This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.

Official Title
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Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Atherectomy+Drug-coated balloon
* Device: Drug-coated balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be between 18 and 85 years old; Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5; Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization; Patent distal popliteal artery and at least one patent distal runoff; Willing to comply with the follow-up evaluation; Written informed consent prior to any study procedures. Exclusion Criteria: Women during pregnancy and lactation, or patients with baby planning; Life expectancy<2 years; Target lesion/vessel with in-stent restenosis Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months Subjects s who are currently participating in other interventional drug or device trials; Angiographic evidence of thrombus within the target vessel Subjects have a history of stroke within 3 months; Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks; Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.

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: Atherectomy+Drug-coated balloon<br>The lesion treated by atherectomy + UltrafreeTM drug-coated balloon. | Device: Atherectomy+Drug-coated balloon<br>* Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group<br>|
| Active Comparator: Drug-coated balloon<br>The lesion treated by UltrafreeTM drug-coated balloon only. | Device: Drug-coated balloon<br>* drug-coated balloon only in the active comparator group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Systolic Velocity Ratio (PSVR) | Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion) | 12-month | 
| Freedom from major adverse limb events（MALEs） | Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Defined as achievement of final residual diameter stenosis of <30% on the procedural completion angiogram, using the assigned device only, whereas lesion success is defined as achievement of <30% residual stenosis using any percutaneous method. | Immediately after endovascular treatment | 
| Procedural success | Defined as technical or device success without the occurrence of major adverse events | During the hospital stay | 
| Primary sustained clinical improvement | Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients | 24-month | 
| Quality of life score | Quality of Life (QOL) score at 24 months; The minimum value is 1, and the maximum value is 7. The higher scores mean a better outcome. | 24-month | 
| EuroQol five dimensions questionnaire (EQ 5D-5L) score | EQ 5D-5L score at 24 months；The minimum value is 0, and the maximum value is 5. The higher scores mean a worse outcome. | 24-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherectomy, drug coated balloon