Clinical trial NCT04861506: The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thromboembolic Disease
Lower Extremity Problem
Endovascular Treatment
Safety Issues
Efficacy, Self
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: First Affiliated Hospital of Zhejiang University
name: Xuanwu Hospital, Beijing
name: Qingdao Haici Hospital
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Second Affiliated Hospital of Suzhou University
name: Chengdu University of Traditional Chinese Medicine
name: Shanghai Zhongshan Hospital
First posted: 2021-04-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Amputation-free survival
timeFrame: post-interventional 12months
measure: Adverse events at post-interventional 1months
timeFrame: post-interventional 1 months
Secondary outcomes:
measure: Technical success rate
timeFrame: Post operation up to 1 day
measure: Clinical-driven Target lesion reintervention(CD-TLR) rate
timeFrame: post-interventional 1,3,6,12 months
measure: Clinical-driven Target vascular reintervention(CD-TVR) rate
timeFrame: post-interventional 1,3,6,12 months
measure: The total time used in the operation
timeFrame: Intraoperative
measure: Primary patency(PP)of the lesions
timeFrame: post-interventional 1,3,6,12 months
measure: Changes of quality of life assessed by VascuQol scale
timeFrame: post-interventional 1,3,6,12 months
measure: Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Fan xin
state: Zhejiang
Study officials:
affiliation: RenJi Hospital
name: Meng Ye
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: Ziheng Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital, Beijing
name: Lianrui Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Haici Hospital
name: Qiang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Zibo Feng
role: PRINCIPAL_INVESTIGATOR
affiliation: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Hongfei Sang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chengdu University of Traditional Chinese Medicine
name: Chunshui He
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Zhenyu Shi
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Hangzhou
name: Xupin Xie
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Hangzhou
name: Jianyun Long
role: PRINCIPAL_INVESTIGATOR
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