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

This trial does not accept healthy volunteers

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 population

Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • endovascular treatment

    Procedure/Surgery

    All 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

400 Participants
are divided into 1 treatment group
Group A: acute or subacute thromboembolic occlusions of lower extremity1 intervention

Trial outcomes

Primary outcomes

1

Amputation-free survival

The amputation-free survival after endovascular surgery

Time frame
post-interventional 12months
2

Adverse events at post-interventional 1months

the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.

Time frame
post-interventional 1 months

Secondary outcomes

1

Technical success rate

Technical success rate

Time frame
Post operation up to 1 day
2

Clinical-driven Target lesion reintervention(CD-TLR) rate

Clinical-driven Target lesion reintervention rate

Time frame
post-interventional 12 months
3

Clinical-driven Target vascular reintervention(CD-TVR) rate

Clinical-driven Target vascular reintervention rate

Time frame
post-interventional 12 months
4

The total time used in the operation

The total time used in the operation

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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