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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Qingdao Haici Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular treatment | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success rate | Post operation up to 1 day |
| Clinical-driven Target lesion reintervention(CD-TLR) rate | Clinical-driven Target lesion reintervention rate |
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Inclusion criteria
Exclusion criteria
Acute or subacute limb ischemia patients with Rutherford classification stage III.
Patients diagnosed with thromboangiitis obliterans.
Patients requring open surgery or hybrid operation after contrast radiography.
Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
Patients at high risk for bleeding.
Pregnant or lactating women.
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.
Patients enrolled in other clinical studies within the past 3 months.
Patients unwilling or refusing to sign the informed consent form.
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Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xin Fang | Contact | +08613867478324 | hzfhfx@126.com | |
| jianyun Long | Contact | +08615715778272 | longjianyun1208@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Ye | RenJi Hospital | Principal Investigator |
| Ziheng Wu | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Lianrui Guo |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fan xin | Recruiting | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41087108 | Derived | Long J, Wang L, Huang C, Xie X, Liu Y, Chen Y, Liu H, Ni Q, Yang S, Wu Z, Guo L, Feng Z, Li Q, He C, Sang H, Shi Z, Ye M, Fang X. Design of the RESOLVE study: a prospective, multicentre, observational, cohort study evaluating the safety and efficacy of endovascular treatment for acute or subacute thromboembolic occlusions of the lower extremity in China. BMJ Open. 2025 Oct 14;15(10):e103283. doi: 10.1136/bmjopen-2025-103283. |
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| OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Second Affiliated Hospital of Suzhou University | OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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|
| post-interventional 12 months |
| Clinical-driven Target vascular reintervention(CD-TVR) rate | Clinical-driven Target vascular reintervention rate | post-interventional 12 months |
| The total time used in the operation | The total time used in the operation | Intraoperative |
| 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 |
| Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions) | Direct medical expenses | 2 years |
| 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 | Principal Investigator |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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