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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Debulking Atherectomy; Procedure: Stent Angioplasty

• Study Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongquan Gu, MD; Phone Number: +8615901598209; Email: gu15901598209@aliyun.com
• Study Contact Backup: Name: Jianming Guo, MD; Phone Number: +8613146369562; Email: guojianming@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Yongquan Gu, MD; Phone Number: 15901598209; Email: gu15901598209@aliyun.com
  • Hebei
    • Shijia Zhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Xiaoqiang Li, MD
  • Jilin
    • Changchun, Jilin, China, 130033
      • Recruiting
      • China-Japan Union Hospital, Jilin University
      • Contact: Jianshi Du, MD
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Mingjin Guo
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital of Fudan University
      • Contact: Zhihui Dong, MD
    • Shanghai, Shanghai, China, 201399
      • Recruiting
      • Shanghai Pudong Hospital, Fudan University
      • Contact: Jingdong Tang, MD
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Bin Hao, MD
    • Xi'an, Shanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital Xi'an Jiaotong University
      • Contact: Shaoying Lu, MD
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Xiangchen, Dai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Debulking Atherectomy; Excimer laser atherectomy combined with drug-coated balloon angioplasty	Procedure: Debulking Atherectomy; Excimer laser atherectomy combined with drug-coated balloon angioplasty
Active Comparator: Stent Angioplasty; Nickel-titanium self-expanding bare stent	Procedure: Stent Angioplasty; Nickel-titanium self-expanding bare stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of surgery-related complications within 30 days after surgery	Including arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation.	30 days
All adverse events and serious adverse events were recorded during the study period.	All adverse events and serious adverse events were recorded during the study period.	12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Fudan University; The Second Hospital of Hebei Medical University; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Tianjin Medical University General Hospital; China-Japan Union Hospital, Jilin University; Shanghai Pudong Hospital; Shanxi Bethune Hospital
• Investigators: Principal Investigator: Yongquan Gu, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: January 2, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: drug-coated balloon; Debulking Atherectomy; Stent Angioplasty; Excimer laser atherectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis
• Other Study ID Numbers: DASALID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No