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

NCT04861506 | Recruiting DMC

• 1 other identifier: The Resolve Study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Amputation-free survival

  The amputation-free survival after endovascular surgery

  post-interventional 12months

• Adverse events at post-interventional 1months

  the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.

  post-interventional 1 months

Secondary Outcomes (7)

• Technical success rate

  Post operation up to 1 day

• Clinical-driven Target lesion reintervention(CD-TLR) rate

  post-interventional 12 months

• Clinical-driven Target vascular reintervention(CD-TVR) rate

  post-interventional 12 months

• The total time used in the operation

  Intraoperative

• Primary patency(PP)of the lesions

  post-interventional 12 months

Study Arms (1)

acute or subacute thromboembolic occlusions of lower extremity

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

Interventions

endovascular treatment PROCEDURE

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.

acute or subacute thromboembolic occlusions of lower extremity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• RenJi Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Qingdao Haici Hospital: collaborator
• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Fan xin

Hangzhou, Zhejiang, 310006, China

RECRUITING

Related Publications (1)

• 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: 10.1136/bmjopen-2025-103283.

  PMID: 41087108 DERIVED

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Meng Ye

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Ziheng Wu

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Lianrui Guo

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Qiang Li

  Qingdao Haici Hospital

  PRINCIPAL INVESTIGATOR

• Zibo Feng

  Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Hongfei Sang

  Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Chunshui He

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Zhenyu Shi

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Xupin Xie

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

• Jianyun Long

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xin Fang

CONTACT

+08613867478324; hzfhfx@126.com

jianyun Long

CONTACT

+08615715778272; longjianyun1208@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital director

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 27, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)