Pressure-wire guidance for below-the-knee artery angioplasty
Official title: 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)
Run by Yonsei University · NCT06879561 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | December 29, 2027 |
| Study ends | August 29, 2028 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT06879561 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.