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

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05670171
• Collaborator: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), The Second Hospital of Hebei Medical University (Other), Shanxi Bethune Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), The Affiliated Hospital of Qingdao University (Other), Shanghai Pudong Hospital (Other), Tianjin Medical University General Hospital (Other), China-Japan Union Hospital, Jilin University (Other), Fudan University (Other)
• Enrollment: 244
• Locations: 10
• Arms: 2
• Anticipated Duration (Months): 35
• Patients Per Site: 24.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Procedure: Debulking Atherectomy; Procedure: Stent Angioplasty	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical-driven revascularization rate of target lesions 12-months after surgery [12 months]

   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.

Secondary Outcome Measures

1. Technical success [Intraoperative]

   Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30%

2. Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery [12 months]

   Primary patency was defined as peak systolic velocity ratio (PSVR) ≤2.4 (stenosis ≤50%) at 12-month follow-up.

3. The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6) [12 months]

   The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)

4. Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6) [6 months and 12 months]

   Wagnar grade changes diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)

5. Rutherford grades at 6 and 12 months postoperatively [6 months and 12 months]

   Rutherford grades at 6 and 12 months postoperatively

6. Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery [6 months and 12 months]

   Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery

7. The number of days of hospitalization [1 month]

   The number of days of hospitalization

8. The cost of hospitalization [1 month]

   The cost of hospitalization

Other Outcome Measures

1. The incidence of surgery-related complications within 30 days after surgery [30 days]

   Including arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation.

2. All adverse events and serious adverse events were recorded during the study period. [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053
2	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei	China	050000
3	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008
4	China-Japan Union Hospital, Jilin University	Changchun	Jilin	China	130033
5	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China	266003
6	Zhongshan Hospital of Fudan University	Shanghai	Shanghai	China	200032
7	Shanghai Pudong Hospital, Fudan University	Shanghai	Shanghai	China	201399
8	Shanxi Bethune hospital	Taiyuan	Shanxi	China	030032
9	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
10	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Yongquan Gu, MD, Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT05670171
• Other Study ID Numbers: DASALID
• First Posted: Jan 4, 2023
• Last Update Posted: Jan 4, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xuanwu Hospital, Beijing: Debulking Atherectomy; drug-coated balloon; Stent Angioplasty; Excimer laser atherectomy
• Additional relevant MeSH terms: Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Ischemia

Study Results

No Results Posted as of Jan 4, 2023