Pressure Wire Guidance for Infrapopliteal Artery Interventions

NCT06879561 | Recruiting

• 1 other identifier: 1-2024-0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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."

Conditions

Chronic Limb-Threatening Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Angiography-guided angioplasty

ACTIVE COMPARATOR

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

Pressure wire-guided angioplasty

EXPERIMENTAL

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

Interventions

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.

Angiography-guided angioplasty

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.

Pressure wire-guided angioplasty

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with chronic limb threatening ischemia (Rutherford 5)
• Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Young-Guk Ko, MD. Division of Cardiology

CONTACT

+82-2-228-8451; ygko@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): December 29, 2027
• Study Completion (Estimated): August 29, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)