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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 aspi

Первичные конечные точки

• Amputation-free survival [Срок оценки: post-interventional 12months]
• Adverse events at post-interventional 1months [Срок оценки: post-interventional 1 months]

Вторичные конечные точки (7)

• Technical success rate [Срок оценки: Post operation up to 1 day]
• Clinical-driven Target lesion reintervention(CD-TLR) rate [Срок оценки: post-interventional 12 months]
• Clinical-driven Target vascular reintervention(CD-TVR) rate [Срок оценки: post-interventional 12 months]
• The total time used in the operation [Срок оценки: Intraoperative]
• Primary patency(PP)of the lesions [Срок оценки: post-interventional 12 months]
• Changes of quality of life assessed by VascuQol scale [Срок оценки: post-interventional 12 months]
• Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.
• Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal.
• The lower extremity artery must have a healthy runoff of at least 10 cm above the ankle with at least one healthy dorsalis pedis artery, medial plantar artery, or lateral plantar artery connecting to the digital artery below the ankle.
• Informed consent signed by patients.

Критерии исключения

• 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.
• Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
• Patients at high risk for bleeding.
• Pregnant or lactating women.
• Patients with other conditions that may complicate study participation or significantly reduce life expectancy (< 2 years), such as tumors, severe liver disease, and cardiac insufficiency.
• Patients enrolled in other clinical studies within the past 3 months.
• Patients unwilling or refusing to sign the informed consent form.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 1 центр

• Fan xin — Ханчжоу

Публикации

• Long J, Wang L, Huang C, Xie X, Liu Y, Chen Y, Liu H, Ni Q, Yang S, Wu Z, Guo L, Feng Z, Li Q, He C, Sang H, Shi Z, Ye M, Fang X. Design of the RESOLVE study: a prospective, multicentre, observational, cohort study evaluating the safety and efficacy of endovascular treatment for acute or subacute thromboembolic occlusions of the lower extremity in China. BMJ Open. 2025 Oct 14;15(10):e103283. doi: PMID 41087108

Идентификаторы

NCT: NCT04861506 · The Resolve Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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