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.

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.

Study Overview

• Status: Recruiting
• Conditions: Safety Issues; Efficacy, Self; Lower Extremity Problem; Thromboembolic Disease; Endovascular Treatment
• Intervention / Treatment: Procedure: endovascular treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: xin Fang; Phone Number: +08613867478324; Email: hzfhfx@126.com
• Study Contact Backup: Name: jianyun Long; Phone Number: +08615715778272; Email: longjianyun1208@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Fan xin
      • Contact: xin fang, master; Phone Number: +08613867478324; Email: hzfhfx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria

1. Patients aged 18 years or older.
2. Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
3. Rutherford classification ranging from 3 to 5.
4. 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.
5. 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.
6. 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.
7. Informed consent signed by patients.

Exclusion criteria

1. Acute or subacute limb ischemia patients with Rutherford classification stage III.
2. Patients diagnosed with thromboangiitis obliterans.
3. Patients requring open surgery or hybrid operation after contrast radiography.
4. Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
5. Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
6. Patients at high risk for bleeding.
7. Pregnant or lactating women.
8. 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.
9. Patients enrolled in other clinical studies within the past 3 months.

10. Patients unwilling or refusing to sign the informed consent form.

    -

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: The Resolve Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No