The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst People's Hospital of Hangzhou

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

Qualifiers

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 design

Treatments tested in this trial

  • endovascular treatment

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators

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