Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.
NCT ID: NCT05670171
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
244 participants
INTERVENTIONAL
2023-01-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Debulking Atherectomy
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Debulking Atherectomy
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Stent Angioplasty
Nickel-titanium self-expanding bare stent
Stent Angioplasty
Nickel-titanium self-expanding bare stent
Interventions
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Debulking Atherectomy
Excimer laser atherectomy combined with drug-coated balloon angioplasty
Stent Angioplasty
Nickel-titanium self-expanding bare stent
Eligibility Criteria
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Inclusion Criteria
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
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
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
40 Years
80 Years
ALL
No
Sponsors
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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
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Principal Investigators
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Yongquan Gu, MD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
China-Japan Union Hospital, Jilin University
Changchun, Jilin, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Pudong Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Bethune hospital
Taiyuan, Shanxi, China
First Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Bi, MD
Role: primary
Xiaoqiang Li, MD
Role: primary
Jianshi Du, MD
Role: primary
Mingjin Guo
Role: primary
Zhihui Dong, MD
Role: primary
Jingdong Tang, MD
Role: primary
Bin Hao, MD
Role: primary
Shaoying Lu, MD
Role: primary
Xiangchen, Dai
Role: primary
Other Identifiers
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DASALID
Identifier Type: -
Identifier Source: org_study_id
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