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NCT Number: NCT06879561

Pressure Wire Guidance for Infrapopliteal Artery Interventions

"• 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."

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Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine

Seoul, South Korea

Location status: Recruiting

Location contact

young Guk ko, MD

CONTACT

[email protected]

82-02-2228-8451

About this study

  • Prospective, singlecenter, open label, randomized controlled study
  • 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.
  • 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.
  • The primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmHg within 1-3 days after the procedure.
  • Clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Thrombocytopenia (platelet <100,000/uL)
  • 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

Treatment and study plan

Angiography-guided angioplasty

Procedure

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.

Pressure wire-guided angioplasty

Procedure

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.

Primary outcomes

  1. Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg

    Time frame: Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapy

    within 3 days after the index endovascular therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Guk Ko, MD. Division of Cardiology

CONTACT

[email protected]

+82-2-228-8451

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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