Evaluating endovascular treatment for blood clots in the legs
Physician-initiated, Prospective, Multi-center, Observational Study: The Safety and Efficiency Result of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
First People's Hospital of Hangzhou · NCT04861506
This study is testing new treatments for blood clots in the legs to see if they are safe and effective for patients with certain types of blockages.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04861506 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of endovascular treatments for patients with acute or subacute thromboembolic occlusions in the lower extremities. It focuses on patients classified under Rutherford stages I to IIb, utilizing advanced tools such as drug-coated balloons and paclitaxel-eluting stents. The study aims to gather real-world data to determine optimal therapies, as current guidelines primarily recommend thrombectomy for stage IIb lesions. By tracking clinical outcomes, the research seeks to provide evidence for the efficacy of endovascular approaches in a broader patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with acute or subacute limb ischemia classified as Rutherford stages I to IIb.
Not a fit: Patients with Rutherford classifications outside the specified range or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with thromboembolic occlusions in the legs, potentially enhancing recovery and quality of life.
How similar studies have performed: While some retrospective studies have shown promise for endovascular treatments in similar cases, this approach remains under-evaluated in prospective trials.
Eligibility criteria
Show full inclusion / exclusion 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.
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Where this trial is running
Hangzhou, Zhejiang
- Fan xin — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Meng Ye — RenJi Hospital
- Study coordinator: xin Fang
- Email: hzfhfx@126.com
- Phone: +08613867478324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thromboembolic Disease, Lower Extremity Problem, Endovascular Treatment, Safety Issues, Efficacy, Self