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

Peripheral Arterial Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670171
• Other study ID #: DASALID
• Status: Recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Yongquan Gu, MD
• Phone: +8615901598209
• Email: gu15901598209[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Debulking Atherectomy
Excimer laser atherectomy combined with drug-coated balloon angioplasty
• Stent Angioplasty
Nickel-titanium self-expanding bare stent

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Union Hospital, Jilin University	Changchun	Jilin
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shanghai Pudong Hospital, Fudan University	Shanghai	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	Shanxi Bethune hospital	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Technical success	Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30%	Intraoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	Rutherford grades at 6 and 12 months postoperatively	Rutherford grades at 6 and 12 months postoperatively	6 months and 12 months
Secondary	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
Secondary	The number of days of hospitalization	The number of days of hospitalization	1 month
Secondary	The cost of hospitalization	The cost of hospitalization	1 month