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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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 aspi

Primary outcome measures

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

Secondary outcome measures (7)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 1 center

• Fan xin — Hangzhou

Publications

• 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

Identifiers

NCT: NCT04861506 · The Resolve Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗