Pressure Wire Guidance for Infrapopliteal Artery Interventions

NCT ID: NCT06879561

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-02
• Study Completion Date: 2028-08-29

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.

Conditions

Chronic Limb-Threatening Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Angiography-guided angioplasty

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Pressure wire-guided angioplasty

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Young-Guk Ko, MD. Division of Cardiology

Role: CONTACT

ygko@yuhs.ac

+82-2-228-8451

Facility Contacts

young Guk ko, MD

Role: primary

ygkp@yuhs.ac

82-02-2228-8451

Other Identifiers

1-2024-0068

Identifier Type: -

Identifier Source: org_study_id