NCT04861506 The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
| NCT ID | NCT04861506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First People's Hospital of Hangzhou |
| Condition | Thromboembolic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2021-04-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria 1. Patients aged 18 years or older. 2. Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb. 3. Rutherford classification ranging from 3 to 5. 4. Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR. 5. Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal. 6. The lower extremity artery must have a healthy runoff of at least 10 cm above the ankle with at least one healthy dorsalis pedis artery, medial plantar artery, or lateral plantar artery connecting to 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 diagnosed with thromboangiitis obliterans. 3. Patients requring open surgery or hybrid operation after contrast radiography. 4. Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months. 5. Patients with known allergies to heparin, low molecular weight heparin, or contrast agents. 6. Patients at high risk for bleeding. 7. Pregnant or lactating women. 8. 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. 9. Patients enrolled in other clinical studies within the past 3 months. 10. Patients unwilling or refusing to sign the informed consent form. \-
Contact & Investigator
Meng Ye
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT04861506 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thromboembolic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04861506 currently recruiting?
Yes, NCT04861506 is actively recruiting participants. Contact the research team at hzfhfx@126.com for enrollment information.
Where is the NCT04861506 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04861506 clinical trial?
NCT04861506 is sponsored by First People's Hospital of Hangzhou. The principal investigator is Meng Ye at RenJi Hospital. The trial plans to enroll 400 participants.