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

Recruiting

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

• Registration Number: NCT04861506
• Lead Sponsor: First People's Hospital of Hangzhou

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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-25
• Study First Posted: 2021-04-27
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amputation-free survival	post-interventional 12months	The amputation-free survival after endovascular surgery
Adverse events at post-interventional 1months	post-interventional 1 months	the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fan xin; 🇨🇳 Hangzhou, Zhejiang, China