An observational study in Thromboembolic Disease, Lower Extremity Problem and Endovascular Treatment, sponsored by First People's Hospital of Hangzhou. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by First People's Hospital of Hangzhou · Observational
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.
According to the Trans-Atlantic Inter-Society Consensus (TASC) II guidelines, acute arterial occlusion which in stage IIb was recommended for thrombectomy. However, with the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, stage IIb patients and some subacute thromboembolic lesions were also effective in some retrospective studies.
Despite The shift of Endovascular-first strategy has been documented in recent literature. There still lack evidence to support either approach have a significant advantage over the thrombectomy. And stage IIb lesions and subacute lesions are often excluded in prospective clinical trials. 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.
288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.
This study's planned enrollment of 400 is close to the median of 440 across 121 observational studies indexed under Thromboembolism.
Browse Thromboembolism studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.
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Exclusion criteria
Patients unwilling or refusing to sign the form.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients are confirmed with acute or subacute thromboembolic occlusions of lower extremity, and which 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 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) for thrombus removal according to the characteristics of the lesions and hospital conditions.
Procedure: endovascular treatment
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.
Amputation-free survival
The amputation-free survival after endovascular surgery
Time frame: post-interventional 12months
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
Technical success rate
Technical success rate
Time frame: Post operation up to 1 day
Clinical-driven Target lesion reintervention(CD-TLR) rate
Clinical-driven Target lesion reintervention rate
Time frame: post-interventional 12 months
Clinical-driven Target vascular reintervention(CD-TVR) rate
Clinical-driven Target vascular reintervention rate
Time frame: post-interventional 12 months
The total time used in the operation
The total time used in the operation
Time frame: Intraoperative
Primary patency(PP)of the lesions
Primary patency(PP)of the lesions
Time frame: post-interventional 12 months
Changes of quality of life assessed by VascuQol scale
Changes of quality of life
Time frame: post-interventional 12 months
Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions)
Direct medical expenses
Time frame: 2 years
Plan to share: No
Started Apr 2021 (actual). Primary completion is estimated for Dec 2025, 56 months after the start.
Of 46 observational studies under Thromboembolism, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's planned 56 months is above that.
How these figures are worked out, and which studies are left out of them.
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First People's Hospital of Hangzhou