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
• Interventions: Procedure: endovascular treatment

• 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: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-25
• Last Update Submitted: 2021-04-25
• Study First Posted: 2021-04-27
• Last Update Posted: 2021-04-27
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients over 18 years old.
2. acute or subacute limb ischemia patients with Rutherford classification stage range from I to IIb.
3. Patients with Rutherford classification range from 3 to 5.
4. The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion. After the angiography and/or performed under digital subtraction angiography(DSA) which confirmed the existing of thrombus, and which is related to occlusions of lower extremity or in-stent restenosis.
5. Pharmacomechanical thrombectomy (PMT) and/or catheter-directed thrombolysis (CDT) was or were used for thrombus removal.
6. The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with 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 with thromboangiitis obliterans.

3. Patients with failure of endovascular treatment, and transfer to open surgery or hybrid operation.

4. People with stroke, cerebral hemorrhage, gastrointestinal bleeding or myocardial infarction and so on in the past 3 months.

5. Patients with known allergy to heparin, low molecular weight heparin and contrast agents.

6. Patients with high bleeding risk.

7. Women during pregnancy and lactation.

8. Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (< 2 years), such as tumors, severe liver disease, cardiac insufficiency.

9. Patients who have been enrolled in other clinical trials in the past 3 months.

10. Patients who are unwilling or refuse to sign the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute or subacute thromboembolic occlusions of lower extremity	endovascular treatment	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 PMT pharmacomechanical thrombectomy (PMT) and catheter-directed thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.

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
The total time used in the operation	Intraoperative	The total time used in the operation
Primary patency(PP)of the lesions	post-interventional 1,3,6,12 months	Primary patency(PP)of the lesions
Clinical-driven Target lesion reintervention(CD-TLR) rate	post-interventional 1,3,6,12 months	Clinical-driven Target lesion reintervention rate
Clinical-driven Target vascular reintervention(CD-TVR) rate	post-interventional 1,3,6,12 months	Clinical-driven Target vascular reintervention rate
Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions)	2 years	Direct medical expenses
Technical success rate	Post operation up to 1 day	Technical success rate
Changes of quality of life assessed by VascuQol scale	post-interventional 1,3,6,12 months	Changes of quality of life

Trial Locations

Locations (1)

Fan xin; 🇨🇳 Hangzhou, Zhejiang, China