Actively Recruiting

Age: 18Years +
All Genders
ID04861506

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

Led by First People's Hospital of Hangzhou · Updated on 2025-09-15

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

First People's Hospital of Hangzhou

Lead Sponsor

R

RenJi Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with acute or subacute thromboembolic occlusions of the lower extremity, conditions where blood clots block arteries in the legs and cause limb ischemia. This observational study aims to assess the safety and clinical outcomes of endovascular treatments in real-world settings, especially for lesions classified as stage IIb or subacute, which are often excluded from clinical trials. The goal is to find optimal therapies, as current guidelines mainly recommend treatments for less severe stages. Participants receive endovascular therapy using approaches such as contralateral femoral artery, ipsilateral antegrade femoral artery, or brachial artery. If lesions are hard to pass, retrograde puncture may be used. Treatment options include mechanical thrombectomy devices, pharmacomechanical thrombectomy, percutaneous aspiration thrombectomy, catheter-directed thrombolysis, or combinations thereof, depending on lesion characteristics and hospital resources. During the study, researchers will monitor participants for up to 12 months after intervention to evaluate amputation-free survival and adverse events. Other assessments include technical success of the procedure, reintervention rates, lesion patency, quality of life changes, operation time, and medical expenses over two years. This comprehensive monitoring aims to track safety, effectiveness, and costs related to the endovascular treatments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 femoropopliteal artery lesion
  • Presence of thrombus confirmed by angiography or digital subtraction angiography associated with occlusions of the lower extremity or in-stent restenosis
  • Undergoing mechanical thrombectomy, pharmacomechanical thrombectomy, percutaneous aspiration thrombectomy, and/or catheter-directed thrombolysis for thrombus removal
  • Lower extremity artery with healthy runoff at least 10 cm above the ankle, including at least one healthy artery connecting to the digital artery below the ankle
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Patients with acute or subacute limb ischemia classified as Rutherford stage III
  • Diagnosis of thromboangiitis obliterans
  • Requiring open surgery or hybrid operation after contrast radiography
  • History of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions within the past 3 months
  • Known allergies to heparin, low molecular weight heparin, or contrast agents
  • High risk for bleeding
  • Pregnant or lactating women
  • Conditions that may complicate participation or reduce life expectancy under 2 years, such as tumors, severe liver disease, or cardiac insufficiency
  • Participation in other clinical studies within the past 3 months
  • Unwilling or refusing to sign informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Intraoperative

Participants receive endovascular treatment for acute or subacute thromboembolic occlusions of the lower extremity. Treatment methods may include mechanical thrombectomy, pharmacomechanical thrombectomy, percutaneous aspiration thrombectomy, and/or catheter-directed thrombolysis depending on the lesion characteristics and hospital conditions.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are followed post-intervention to monitor safety and clinical outcomes including adverse events, patency of lesions, and reintervention rates.

Visits at 1 month and periodically up to 12 months post-intervention

Trial Site Locations

Total: 1 location

1

Fan xin

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

X

xin Fang

J

jianyun Long

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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.

Jianyun Long, Linjun Wang, Changpin Huang...

https://pubmed.ncbi.nlm.nih.gov/41087108