Peripheral Arterial Disease
Conditions
Keywords
Debulking Atherectomy, drug-coated balloon, Stent Angioplasty, Excimer laser atherectomy
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.
Interventions
PROCEDUREDebulking Atherectomy
Excimer laser atherectomy combined with drug-coated balloon angioplasty
PROCEDUREStent Angioplasty
Nickel-titanium self-expanding bare stent
Sponsors
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
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Intraoperative | Intraoperative angiography will demonstrated residual stenosis of the treated vessel \<30% |
| 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. |
| 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) |
| 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) |
| The number of days of hospitalization | 1 month | The number of days of hospitalization |
| The cost of hospitalization | 1 month | The cost of hospitalization |
| Rutherford grades at 6 and 12 months postoperatively | 6 months and 12 months | Rutherford grades at 6 and 12 months postoperatively |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYongquan Gu, MD
Backup ContactJianming Guo, MD
Outcome results
None listed