RecruitingNCT04861506

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

Physician-initiated, Prospective, Multi-center, Observational Study: The Safety and Efficiency Result of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.

Sponsor

First People's Hospital of Hangzhou

Enrollment

400 participants

Start Date

Apr 1, 2021

Study Type

OBSERVATIONAL

Conditions

Efficacy, Self Safety Issues Thromboembolic Disease Endovascular Treatment Lower Extremity Problem

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of endovascular (catheter-based) procedures to remove blood clots blocking arteries in the lower limbs, causing acute or subacute limb ischemia — a condition where a limb does not receive enough blood flow and may be at risk of permanent damage or amputation. Various techniques including mechanical thrombectomy, aspiration, and clot-dissolving therapy are used, and the study aims to identify which approaches lead to the best outcomes. Patients with confirmed clot blockage in the femoropopliteal artery (the main artery of the thigh and knee area) who undergo endovascular treatment will be followed for outcomes such as limb salvage, procedural success, and complications. You may be eligible if: - You are 18 years or older - You have acute or subacute limb ischemia (Rutherford stage I–IIb) with confirmed thrombus in the femoropopliteal artery - A wire was successfully passed through the blockage and endovascular treatment performed - You have at least 10 cm of healthy artery above the ankle with patent foot vessels - You have signed informed consent You may NOT be eligible if: - You have critical limb ischemia (Rutherford stage III) - You have thromboangiitis obliterans (Buerger's disease) - You had a stroke, brain bleed, GI bleed, or heart attack within the past 3 months - You are pregnant or breastfeeding - You have allergies to heparin or contrast agents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREendovascular 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.