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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| Shanxi Bethune Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Debulking Atherectomy | Active Comparator | Excimer laser atherectomy combined with drug-coated balloon angioplasty |
|
| Stent Angioplasty | Active Comparator | Nickel-titanium self-expanding bare stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debulking Atherectomy | Procedure | Excimer laser atherectomy combined with drug-coated balloon angioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Intraoperative angiography will demonstrated residual stenosis of the treated vessel <30% | Intraoperative |
| Primary patency rate in patients with claudication (Rutherford grades 1-3) 12 -months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| All adverse events and serious adverse events were recorded during the study period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Gu, MD | Contact | +8615901598209 | gu15901598209@aliyun.com | |
| Jianming Guo, MD | Contact | +8613146369562 | guojianming@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongquan Gu, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| 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 |
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| Stent Angioplasty | Procedure | Nickel-titanium self-expanding bare stent |
|
Primary patency was defined as peak systolic velocity ratio (PSVR) ≤2.4 (stenosis ≤50%) at 12-month follow-up.
| 12 months |
| 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 |
| 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 |
| Rutherford grades at 6 and 12 months postoperatively | Rutherford grades at 6 and 12 months postoperatively | 6 months and 12 months |
| 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 |
| The number of days of hospitalization | The number of days of hospitalization | 1 month |
| The cost of hospitalization | The cost of hospitalization | 1 month |
All adverse events and serious adverse events were recorded during the study period. |
| 12 months |
| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
|
| China-Japan Union Hospital, Jilin University | Recruiting | Changchun | Jilin | 130033 | China |
|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266003 | China |
|
| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Shanghai Pudong Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201399 | China |
|
| Shanxi Bethune hospital | Recruiting | Taiyuan | Shanxi | 030032 | China |
|
| First Affiliated Hospital Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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