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Pressure Wire Guidance for Infrapopliteal Artery Interventions

NCT06879561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-02

No results posted yet for this study

Summary

"• 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."

Conditions

  • Chronic Limb-Threatening Ischemia

Interventions

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.

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2027-12-29
Completion
2028-08-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06879561 on ClinicalTrials.gov