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

NCT05670171 | Unknown DMC

• 1 other identifier: DASALID
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 10

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.

Conditions

Peripheral Arterial Disease

Keywords

Debulking Atherectomy; drug-coated balloon; Stent Angioplasty; Excimer laser atherectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Technical success

  Intraoperative

• Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery

  12 months

• 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)

  6 months and 12 months

• Rutherford grades at 6 and 12 months postoperatively

  6 months and 12 months

Other Outcomes (2)

• The incidence of surgery-related complications within 30 days after surgery

  30 days

• All adverse events and serious adverse events were recorded during the study period.

  12 months

Study Arms (2)

Debulking Atherectomy

ACTIVE COMPARATOR

Excimer laser atherectomy combined with drug-coated balloon angioplasty

Procedure: Debulking Atherectomy

Stent Angioplasty

ACTIVE COMPARATOR

Nickel-titanium self-expanding bare stent

Procedure: Stent Angioplasty

Interventions

Debulking Atherectomy PROCEDURE

Excimer laser atherectomy combined with drug-coated balloon angioplasty

Debulking Atherectomy

Stent Angioplasty PROCEDURE

Nickel-titanium self-expanding bare stent

Stent Angioplasty

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Shanxi Bethune Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Shanghai Pudong Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• Fudan University: collaborator

Study Sites (10)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

China-Japan Union Hospital, Jilin University

Changchun, Jilin, 130033, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Pudong Hospital, Fudan University

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

Shanxi Bethune hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

First Affiliated Hospital Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Yongquan Gu, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongquan Gu, MD

CONTACT

+8615901598209; gu15901598209@aliyun.com

Jianming Guo, MD

CONTACT

+8613146369562; guojianming@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: January 4, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

CN (10)