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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861506
• Other study ID #: The Resolve Study
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2021
• Source: First People's Hospital of Hangzhou
• Contact: xin Fang
• Phone: +08613867478324
• Email: hzfhfx[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

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

Intervention

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 catheter-directed thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.

Locations

Country	Name	City	State
China	Fan xin	Hangzhou	Zhejiang

Sponsors (9)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou	Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Qingdao haici hospital, RenJi Hospital, Second Affiliated Hospital of Suzhou University, Shanghai Zhongshan Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

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