About this trial
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older.
Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
Rutherford classification ranging from 3 to 5.
Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR.
Disqualifiers
Acute or subacute limb ischemia patients with Rutherford classification stage III.
Patients diagnosed with thromboangiitis obliterans.
Patients requring open surgery or hybrid operation after contrast radiography.
Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
Trial population
Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.
Trial design
Case-only
Prospective
Treatments tested in this trial
endovascular treatment
Procedure/SurgeryAll the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods such as pharmacomechanical thrombectomy (PMT) and mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT)and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.
Treatment groups
Trial outcomes
Primary outcomes
Amputation-free survival
The amputation-free survival after endovascular surgery
Adverse events at post-interventional 1months
the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.
Secondary outcomes
Technical success rate
Technical success rate
Clinical-driven Target lesion reintervention(CD-TLR) rate
Clinical-driven Target lesion reintervention rate
Clinical-driven Target vascular reintervention(CD-TVR) rate
Clinical-driven Target vascular reintervention rate
The total time used in the operation
The total time used in the operation
Sponsors and contacts
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First People's Hospital of Hangzhou
Lead sponsor
Hangzhou Cancer Hospital
Sponsor institution
RenJi Hospital
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Qingdao Haici Hospital
Collaborator
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Second Affiliated Hospital of Suzhou University
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
Shanghai Zhongshan Hospital
Collaborator