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

Capital Medical University

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Procedure: Stent Angioplasty; Procedure: Debulking Atherectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05670171

DASALID

Details and patient eligibility

About

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.

Enrollment: 244 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 40-80 years old
2. Rutherford grade 2 to 5
3. Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicated with diabetes
4. The target vessel diameter ≥4mm
5. The total target length of the lesion is 30-210mm
6. The subject is able and willing to comply with all requirements, including 12-month follow-up and evaluation, voluntary participation and informed consen
7. 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)
8. Patients with at least one infrapopliteal artery for patency of the affected lateral foot before or after intraoperative treatment (stenosis ≤50%)

Exclusion criteria

1. Patients with vasculitis or Berger disease
2. Patients with contraindications to antiplatelet, anticoagulant and thrombolytic drugs
3. Patients who are allergic to contrast agents and nickel titanium materials
4. Patients with severe coagulation dysfunction or severe infection that is not under control and should not undergo surgery
5. Severe renal dysfunction (creatinine > 221umol/L)
6. Patients who received local or systemic thrombolytic therapy within 48 hours before surgery
7. Patients who had acute myocardial infarction within 30 days before surgery
8. Patients who had undergone major surgical procedures (heart, abdominal, or peripheral vascular open surgery) within 30 days before surgery
9. Patients who had a stroke within 6 months before surgery
10. 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
11. Patients with end-stage renal disease
12. Patients with previous major amputation of the target limb or restenosis after stent or bypass surgery for the target lesion
13. Patients with perforation, dissection, or other vascular injury requiring stenting or surgical operation in the approach or target vessel prior to enrollment
14. Patients with a life expectancy of < 12 months
15. A woman who is pregnant or breastfeeding
16. Patients who are participating in clinical trials of other drugs or devices that do not meet trial endpoints
17. Patients considered unsuitable for this trial by the investigators Exclusion criteria for angiography
18. Patients with severe calcification of the target lesions
19. Patients with aneurysms in the target vessels
20. Patients with acute or subacute thrombus in the target vessel
21. Patients with artificial vessels placed in the limb on the same side of the target vessel

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

Debulking Atherectomy

Active Comparator group

Description:

Excimer laser atherectomy combined with drug-coated balloon angioplasty

Treatment:

Procedure: Debulking Atherectomy

Stent Angioplasty

Active Comparator group

Description:

Nickel-titanium self-expanding bare stent

Treatment:

Procedure: Stent Angioplasty