Phase
Condition
Vascular Diseases
Peripheral Arterial Occlusive Disease
Atherosclerosis
Treatment
N/AClinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 40-80 years old
- Rutherford grade 2 to 5
- Patients clinically diagnosed with arteriosclerosis obliterans of lower extremity (stenosis of lower extremity arteries greater than 70% or occlusion) and complicatedwith diabetes
- The target vessel diameter ≥4mm
- The total target length of the lesion is 30-210mm
- The subject is able and willing to comply with all requirements, including 12-monthfollow-up and evaluation, voluntary participation and informed consen
- Patients with ipsilateral iliac artery inflow tract patency (stenosis ≤50%) oripsilateral iliac artery inflow tract lesions and successful management (residualstenosis < 30% after treatment, no severe (≥ grade D) flow-limiting dissection , nothrombosis, embolism or other serious adverse events)
- Patients with at least one infrapopliteal artery for patency of the affected lateralfoot before or after intraoperative treatment (stenosis ≤50%)
Exclusion
Exclusion Criteria:
- Patients with vasculitis or Berger disease
- Patients with contraindications to antiplatelet, anticoagulant and thrombolytic drugs
- Patients who are allergic to contrast agents and nickel titanium materials
- Patients with severe coagulation dysfunction or severe infection that is not undercontrol and should not undergo surgery
- Severe renal dysfunction (creatinine > 221umol/L)
- Patients who received local or systemic thrombolytic therapy within 48 hours beforesurgery
- Patients who had acute myocardial infarction within 30 days before surgery
- Patients who had undergone major surgical procedures (heart, abdominal, or peripheralvascular open surgery) within 30 days before surgery
- Patients who had a stroke within 6 months before surgery
- Patients whose target arteries had received endovascular surgery within 14 days priorto surgery and patients who had other elective surgery plans during the study period
- Patients with end-stage renal disease
- Patients with previous major amputation of the target limb or restenosis after stentor bypass surgery for the target lesion
- Patients with perforation, dissection, or other vascular injury requiring stenting orsurgical operation in the approach or target vessel prior to enrollment
- Patients with a life expectancy of < 12 months
- A woman who is pregnant or breastfeeding
- Patients who are participating in clinical trials of other drugs or devices that donot meet trial endpoints
- Patients considered unsuitable for this trial by the investigators Exclusion criteriafor angiography
- Patients with severe calcification of the target lesions
- Patients with aneurysms in the target vessels
- Patients with acute or subacute thrombus in the target vessel
- Patients with artificial vessels placed in the limb on the same side of the targetvessel
Study Design
Connect with a study center
Xuanwu Hospital, Capital Medical University
Beijing, Beijing 100053
ChinaActive - Recruiting
The Second Hospital of Hebei Medical University
Shijia Zhuang, Hebei 050000
ChinaActive - Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
China-Japan Union Hospital, Jilin University
Changchun, Jilin 130033
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266003
ChinaActive - Recruiting
Shanghai Pudong Hospital, Fudan University
Shanghai, Shanghai 201399
ChinaActive - Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Shanxi Bethune hospital
Taiyuan, Shanxi 030032
ChinaActive - Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shanxi 710061
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin 300052
ChinaActive - Recruiting
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