Evaluating endovascular treatment for blocked arteries below the knee
Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study
Xuanwu Hospital, Beijing · NCT06009146
This study is testing if a new type of treatment for blocked arteries below the knee can help over 3,000 patients with leg pain and circulation problems feel better and stay safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06009146 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center observational study that assesses the effectiveness and safety of endovascular therapy for patients with infrapopliteal arterial occlusive disease. Conducted across 38 centers, the study aims to enroll over 3000 patients suffering from conditions ranging from intermittent claudication to chronic limb ischemia. The focus is on real-world outcomes of treatments such as drug-coated balloons, angioplasty, and atherectomy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with infrapopliteal artery disease requiring endovascular treatment.
Not a fit: Patients who are allergic to necessary medications or unable to undergo endovascular therapy for other medical reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatments for patients with severe leg artery blockages, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with similar endovascular approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up; Exclusion Criteria: Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；
Where this trial is running
Beijing, Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Lianrui Guo, M.D.
- Email: lianruiguo@sina.com
- Phone: +8613671009746
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: Infrapopliteal Artery Occlusive Disease, Endovascular Treatment, Infrapopliteal Artery Disease, Drug-coated Balloons, Angioplasty, Atherectomy