Pressure Wire Guidance for Infrapopliteal Artery Interventions

Not Applicable

Not yet recruiting

• Conditions: Chronic Limb-Threatening Ischemia

• Registration Number: NCT06879561
• Lead Sponsor: Yonsei University

Brief 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."

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-03-31
• Primary Completion: 2026-08-29
• Study Completion: 2026-08-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg	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