Pressure-wire guidance for below-the-knee artery angioplasty
Impact of Pressure Wire-guidance Versus Angiography-guidance for Infrapopliteal Artery Interventions on Post-procedural Perfusion Status and Wound Healing in Patients With Chronic Limb Threatening Ischemia (PERFECT-CLI)
This will test if using a pressure wire to guide below-the-knee balloon angioplasty helps people with severe limb-threatening ischemia of the anterior or posterior tibial arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06879561 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, open-label randomized comparison of two guidance strategies during balloon angioplasty for anterior or posterior tibial artery lesions in patients with Rutherford category 5 chronic limb-threatening ischemia. One group will receive angioplasty guided by standard angiography alone while the other group will use a pressure wire in addition to angiography to guide treatment decisions. A total of 100 patients will be randomized 1:1 and treated with balloon angioplasty for lesions ≥10 cm. The primary endpoint is achieving skin perfusion pressure ≥50 mmHg within 1–3 days after the procedure, with clinical follow-up at 1, 3, and 6 months to track wound healing and events.
Who should consider this trial
Good fit: Ideal candidates are adults (≥19 years) with Rutherford category 5 chronic limb-threatening ischemia and anterior or posterior tibial artery lesions of at least 10 cm who are planned for endovascular balloon angioplasty.
Not a fit: Patients with acute limb ischemia, contraindications to antiplatelet/anticoagulant therapy or recent major bleeding, pregnant patients, or those with life expectancy under one year are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve skin perfusion and increase rates of wound healing and limb salvage after below-the-knee angioplasty.
How similar studies have performed: Pressure-wire guidance is well established in coronary interventions and has shown some promise in peripheral artery procedures, but randomized data specifically for infrapopliteal lesions are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with chronic limb threatening ischemia (Rutherford 5) * Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years Exclusion Criteria: * Acute limb ischemia * Contraindication to antiplatelet or anticoagulation agents: 1. Thrombocytopenia (platelet \<100,000/uL) 2. Previous cerebral hemorrhage, GI bleeding, other reasons for increased bleeding risk within 6 months * Pregnant women or women with potential childbearing * Life expectancy \< 1 year
Where this trial is running
Seoul
- Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Young-Guk Ko, MD. Division of Cardiology
- Email: ygko@yuhs.ac
- Phone: +82-2-228-8451
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.