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

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

Interventions

PROCEDURE

Debulking Atherectomy

Excimer laser atherectomy combined with drug-coated balloon angioplasty

PROCEDURE

Stent Angioplasty

Nickel-titanium self-expanding bare stent

Sponsors & Collaborators

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

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Shanghai Pudong Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Yongquan Gu, MD · Xuanwu Hospital, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-31

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations