Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.

Study Overview
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Brief Summary
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In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter, randomized controlled, non-inferiority trial. The main surgical methods included stent angioplasty group (Nickel-titanium self-expanding bare stent) and debulking atherectomy group (Excimer laser atherectomy combined with drug-coated balloon angioplasty). The sample size was 244 patients, and the patients were followed up at 30 days, 180 days, and 365 days after operation.

Official Title
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Assessment the Safety and Efficacy of Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease: A Multicenter, Randomized, Controlled Study.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Debulking Atherectomy
* Procedure: Stent Angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-80 years old Rutherford grade 2 to 5 Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicated with diabetes The target vessel diameter ≥4mm The total target length of the lesion is 30-210mm The subject is able and willing to comply with all requirements, including 12-month follow-up and evaluation, voluntary participation and informed consen Patients with ipsilateral iliac artery inflow tract patency (stenosis ≤50%) or ipsilateral iliac artery inflow tract lesions and successful management (residual stenosis < 30% after treatment, no severe (≥ grade D) flow-limiting dissection , no thrombosis, embolism or other serious adverse events) Patients with at least one infrapopliteal artery for patency of the affected lateral foot before or after intraoperative treatment (stenosis ≤50%) Exclusion Criteria: Patients with vasculitis or Berger disease Patients with contraindications to antiplatelet, anticoagulant and thrombolytic drugs Patients who are allergic to contrast agents and nickel titanium materials Patients with severe coagulation dysfunction or severe infection that is not under control and should not undergo surgery Severe renal dysfunction (creatinine > 221umol/L) Patients who received local or systemic thrombolytic therapy within 48 hours before surgery Patients who had acute myocardial infarction within 30 days before surgery Patients who had undergone major surgical procedures (heart, abdominal, or peripheral vascular open surgery) within 30 days before surgery Patients who had a stroke within 6 months before surgery Patients whose target arteries had received endovascular surgery within 14 days prior to surgery and patients who had other elective surgery plans during the study period Patients with end-stage renal disease Patients with previous major amputation of the target limb or restenosis after stent or bypass surgery for the target lesion Patients with perforation, dissection, or other vascular injury requiring stenting or surgical operation in the approach or target vessel prior to enrollment Patients with a life expectancy of < 12 months A woman who is pregnant or breastfeeding Patients who are participating in clinical trials of other drugs or devices that do not meet trial endpoints Patients considered unsuitable for this trial by the investigators Exclusion criteria for angiography Patients with severe calcification of the target lesions Patients with aneurysms in the target vessels Patients with acute or subacute thrombus in the target vessel Patients with artificial vessels placed in the limb on the same side of the target vessel

Ages Eligible for Study
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Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Debulking Atherectomy<br>Excimer laser atherectomy combined with drug-coated balloon angioplasty | Procedure: Debulking Atherectomy<br>* Excimer laser atherectomy combined with drug-coated balloon angioplasty<br>|
| Active Comparator: Stent Angioplasty<br>Nickel-titanium self-expanding bare stent | Procedure: Stent Angioplasty<br>* Nickel-titanium self-expanding bare stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical-driven revascularization rate of target lesions 12-months after surgery | Clinically driven revascularization of target lesions was defined as a reduction of ABI ≥20% or >0.15 due to clinical symptoms or compared to the ABI after the initial surgery, any re-interventional therapy required for the target lesion. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30% | Intraoperative | 
| Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery | Primary patency was defined as peak systolic velocity ratio (PSVR) ≤2.4 (stenosis ≤50%) at 12-month follow-up. | 12 months | 
| The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6) | The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6) | 12 months | 
| Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6) | Wagnar grade changes diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6) | 6 months and 12 months | 
| Rutherford grades at 6 and 12 months postoperatively | Rutherford grades at 6 and 12 months postoperatively | 6 months and 12 months | 
| Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery | Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery | 6 months and 12 months | 
| The number of days of hospitalization | The number of days of hospitalization | 1 month | 
| The cost of hospitalization | The cost of hospitalization | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy