Pressure Wire Guidance for Infrapopliteal Artery Interventions

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)

"• A prospective, single-center randomized controlled comparison trial.

• A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria.
• Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group.
• Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions.
• In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis >50% or flow-limiting dissection.
• In the Pressure Wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. Optimal pressure gradient is less than 10 mmHg by measurement using a Pressure Wire.
• The primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmHg within 1-3 days after the index procedure.
• Patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events."

Study Overview

• Status: Recruiting
• Conditions: Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Procedure: Angiography-guided angioplasty; Procedure: Pressure wire-guided angioplasty

Detailed Description

1. Prospective, singlecenter, open label, randomized controlled study
2. Eligible patients with chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be randomized to pressure wire-guided or angiography-guided groups.
3. All patients will undergo balloon angioplasty for anterior or posterior tibial artery lesions, with the angiography-guided group aiming for optimal procedural results based on angiography, and the pressure wire-guided group aiming for optimal results based on both angiography and pressure gradient measurements.
4. The primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmHg within 1-3 days after the procedure.
5. Clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young-Guk Ko, MD. Division of Cardiology; Phone Number: +82-2-228-8451; Email: ygko@yuhs.ac

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine
    • Contact: young Guk ko, MD; Phone Number: 82-02-2228-8451; Email: ygkp@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiography-guided angioplasty; In this group, balloon angioplasty will be performed on the target infrapopliteal artery lesion to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis >50% or any flow-limiting dissection.	Procedure: Angiography-guided angioplasty; Balloon angioplasty will be performed on the target infrapopliteal artery lesion to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis >50% or any flow-limiting dissection.
Experimental: Pressure wire-guided angioplasty; In this gorup, balloon angioplasty will be performed on the target infrapopliteal artery lesions to achieve an optimal procedural result, as determined by the pressure gradient across the target lesion. An optimal procedural result is defined as pressure gradient less than 10 mmHg, measured using a Pressure Wire.	Procedure: Pressure wire-guided angioplasty; Balloon angioplasty will be performed on the target infrapopliteal artery lesions to achieve an optimal procedural result, as determined by the pressure gradient across the target lesion. An optimal procedural result is defined as pressure gradient less than 10 mmHg, measured using a Pressure Wire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg	within 3 days after the index endovascular therapy	Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapy

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Estimated): December 29, 2027
• Study Completion (Estimated): August 29, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: 1-2024-0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No