Comparing two methods for treating limb ischaemia in diabetic patients

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.

This study is testing whether a new method called debulking atherectomy is as safe and effective as stent angioplasty for treating poor blood flow in the legs of people with diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 10 sites (Beijing, Beijing and 9 other locations)
• Trial ID: NCT05670171 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of debulking atherectomy versus stent angioplasty for treating limb ischaemia caused by diabetic lower limb atherosclerosis-occlusive disease. It is a prospective, multicenter, randomized controlled, non-inferiority trial involving 244 patients. Participants will be assigned to either the stent angioplasty group or the debulking atherectomy group, with follow-up evaluations at 30, 180, and 365 days post-operation to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with Rutherford grade 2 to 5 limb ischaemia and significant lower extremity artery stenosis or occlusion, complicated by diabetes.

Not a fit: Patients with vasculitis or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from limb ischaemia due to diabetic atherosclerosis.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing and 9 other locations

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
• The Second Hospital of Hebei Medical University — Shijia Zhuang, Hebei, China (Recruiting)
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
• China-Japan Union Hospital, Jilin University — Changchun, Jilin, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• Zhongshan Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
• Shanghai Pudong Hospital, Fudan University — Shanghai, Shanghai, China (Recruiting)
• Shanxi Bethune hospital — Taiyuan, Shanxi, China (Recruiting)
• First Affiliated Hospital Xi'an Jiaotong University — Xi'an, Shanxi, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Yongquan Gu, MD — Xuanwu Hospital, Beijing
• Study coordinator: Yongquan Gu, MD

Conditions Peripheral Arterial Disease; Debulking Atherectomy; drug-coated balloon; Stent Angioplasty; Excimer laser atherectomy