Clinical trial NCT05670171: Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Debulking Atherectomy
drug-coated balloon
Stent Angioplasty
Excimer laser atherectomy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The Second Hospital of Hebei Medical University
name: Shanxi Bethune Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: The Affiliated Hospital of Qingdao University
name: Shanghai Pudong Hospital
name: Tianjin Medical University General Hospital
name: China-Japan Union Hospital, Jilin University
name: Fudan University
First posted: 2023-01-04
Enrollment: 244
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical-driven revascularization rate of target lesions 12-months after surgery
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: Intraoperative
measure: Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery
timeFrame: 12 months
measure: The rate of unexpected major amputations 12 months after surgery in patients with severe ischemia (Rutherford grades 4-6)
timeFrame: 12 months
measure: Wagnar grade changes of diabetic foot ulcers at 6 months and 12 months after surgery (Rutherford Grade 4-6)
timeFrame: 6 months and 12 months
measure: Rutherford grades at 6 and 12 months postoperatively
timeFrame: 6 months and 12 months
measure: Changes in ankle-brachial index (ABI) at 6 and 12 months after surgery
timeFrame: 6 months and 12 months
measure: The number of days of hospitalization
timeFrame: 1 month
measure: The cost of hospitalization
timeFrame: 1 month
Other outcomes:
measure: The incidence of surgery-related complications within 30 days after surgery
timeFrame: 30 days
measure: All adverse events and serious adverse events were recorded during the study period.
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital, Jilin University
state: Jilin
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital, Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Yongquan Gu, MD
role: PRINCIPAL_INVESTIGATOR
References: