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

Last updated: January 2, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Peripheral Arterial Occlusive Disease

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT05670171
DASALID
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 complicatedwith 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-monthfollow-up and evaluation, voluntary participation and informed consen
  7. Patients with ipsilateral iliac artery inflow tract patency (stenosis ≤50%) oripsilateral iliac artery inflow tract lesions and successful management (residualstenosis < 30% after treatment, no severe (≥ grade D) flow-limiting dissection , nothrombosis, embolism or other serious adverse events)
  8. Patients with at least one infrapopliteal artery for patency of the affected lateralfoot before or after intraoperative treatment (stenosis ≤50%)

Exclusion

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 undercontrol and should not undergo surgery
  5. Severe renal dysfunction (creatinine > 221umol/L)
  6. Patients who received local or systemic thrombolytic therapy within 48 hours beforesurgery
  7. Patients who had acute myocardial infarction within 30 days before surgery
  8. Patients who had undergone major surgical procedures (heart, abdominal, or peripheralvascular 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 priorto 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 stentor bypass surgery for the target lesion
  13. Patients with perforation, dissection, or other vascular injury requiring stenting orsurgical 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 donot meet trial endpoints
  17. Patients considered unsuitable for this trial by the investigators Exclusion criteriafor 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 targetvessel

Study Design

Total Participants: 244
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100053
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijia Zhuang, Hebei 050000
    China

    Active - Recruiting

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • China-Japan Union Hospital, Jilin University

    Changchun, Jilin 130033
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266003
    China

    Active - Recruiting

  • Shanghai Pudong Hospital, Fudan University

    Shanghai, Shanghai 201399
    China

    Active - Recruiting

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanxi Bethune hospital

    Taiyuan, Shanxi 030032
    China

    Active - Recruiting

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

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