Actively Recruiting
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)
Led by Yonsei University · Updated on 2025-12-02
100
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods of guiding balloon angioplasty treatment for patients with chronic limb-threatening ischemia affecting the anterior or posterior tibial arteries. This prospective, single-center randomized controlled trial will compare pressure wire-guided angioplasty to angiography-guided angioplasty. The study aims to determine which method better improves blood flow and wound healing in these patients. Participants will be randomly assigned to one of two groups. In the angiography-guided group, balloon angioplasty will be performed to achieve good blood flow based on imaging results, defined as less than 50% narrowing and no flow-blocking dissection. In the pressure wire-guided group, the procedure will be guided by both imaging and pressure measurements, targeting a pressure gradient below 10 mmHg across the treated lesion using a Pressure Wire device. After treatment, participants will be monitored closely with follow-up visits at 1, 3, and 6 months to assess wound healing and clinical outcomes. The main measure of success is achieving skin perfusion pressure of 50 mmHg or higher within 1 to 3 days after the procedure. The study will also track clinical events during the follow-up period to evaluate the treatment effects over time.
CONDITIONS
Brief Title
Pressure Wire Guidance for Infrapopliteal Artery Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with chronic limb threatening ischemia (Rutherford category 5)
- Lesions in anterior tibial artery or posterior tibial artery at least 10 cm in length
- Age 19 years or older
You will not qualify if you...
- Acute limb ischemia
- Contraindication to antiplatelet or anticoagulation agents, including thrombocytopenia (platelet <100,000/uL)
- Previous cerebral hemorrhage, gastrointestinal bleeding, or other bleeding risk within 6 months
- Pregnant women or women with potential childbearing
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day and up to 3 days post-procedure
Participants undergo balloon angioplasty on target infrapopliteal artery lesions guided by either pressure wire measurements or angiography to achieve optimal blood flow.
1 procedure visit and 1 to 3 days of monitoring visits
Duration - 6 months
Participants are monitored clinically to assess wound healing and clinical events after the procedure.
Visits at 1 month, 3 months, and 6 months post-procedure
Trial Site Locations
Total: 1 location
1
Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young-Guk Ko, MD. Division of Cardiology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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