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

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Debulking Atherectomy; Procedure: Stent Angioplasty

• Registration Number: NCT05670171
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-04
• Study Start: 2023-01
• Study First Submitted QC: 2023-01-02
• Last Update Submitted: 2023-01-02
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Debulking Atherectomy	Debulking Atherectomy	Excimer laser atherectomy combined with drug-coated balloon angioplasty
Stent Angioplasty	Stent Angioplasty	Nickel-titanium self-expanding bare stent

Primary Outcome Measures

Name	Time	Method
Clinical-driven revascularization rate of target lesions 12-months after surgery	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijia Zhuang, Hebei, China

China-Japan Union Hospital, Jilin University; 🇨🇳 Changchun, Jilin, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pudong Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanxi Bethune hospital; 🇨🇳 Taiyuan, Shanxi, China

First Affiliated Hospital Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China