Evaluating endovascular treatment for complex femoropopliteal artery lesions
Physician-initiated, Prospective, Multi-center，Observational Study: The Efficacy of Endovascular Treatment in Femoropopliteal Occlusive Disease (FPOD) With TransAtlantic InterSociety Consensus (TASC) C and D Lesions
RenJi Hospital · NCT04698304
This study is testing whether advanced treatments for tough artery blockages in the leg can help patients feel better and improve their blood flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04698304 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of endovascular treatments for patients with TASC C and D femoropopliteal occlusive disease. It focuses on utilizing advanced tools such as drug-coated balloons and paclitaxel-eluting stents to treat challenging arterial lesions that are often excluded from clinical trials. The study will track clinically relevant outcomes to determine the optimal therapeutic approaches for these complex cases. By including patients with varying degrees of Rutherford classification, the study seeks to provide real-world evidence on the effectiveness of these interventions.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with Rutherford classification ranging from 3 to 6 and specific anatomical criteria for their lower extremity arteries.
Not a fit: Patients with less severe femoropopliteal lesions or those who do not meet the anatomical and clinical criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with complex femoropopliteal occlusive disease.
How similar studies have performed: While there is a shift towards endovascular-first strategies in recent literature, this study addresses a gap in evidence for TASC D lesions, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years old 2. Patients with Rutherford classification range from 3 to 6 3. If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study 4. 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 5. 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 6. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled 7. For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery 8. Informed consent signed by patients Exclusion Criteria: 1. Patients who are unwilling or refuse to sign the informed consent form 2. Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism 3. Patients with thromboangiitis obliterans 4. Patients with failure of endovascular treatment, and transferred to bypass surgery 5. Patients who underwent surgical atherectomy for common femoral artery occlusive lesions 6. Patients with known allergy to heparin, low molecular weight heparin and contrast agents 7. Patients who have been enrolled in other clinical trials in the past 3 months 8. Women during pregnancy and lactation 9. Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (\< 3 years), such as tumors, severe liver disease, cardiac insufficiency
Where this trial is running
Shanghai, Shanghai
- Renji Hospital — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Ni Qihong, M.D.
- Email: niqihong1989@163.com
- Phone: +8615801900772
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: Femoropopliteal Occlusive Disease, endovascular treatment, patency rate