IVUS Guidance in BTK Interventions

Summary

Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb. It is often treated with endovascular therapy (EVT), a minimally invasive procedure that opens the blocked artery, but the artery frequently narrows or closes again afterward. These procedures are usually guided by X-ray pictures taken with dye (angiography). Intravascular ultrasound (IVUS) is an imaging tool that uses a small catheter inside the artery to give a more detailed view of the vessel, which may help doctors open it more completely. It is not yet clear whether adding IVUS improves results below the knee.

This study is testing whether guiding treatment with IVUS plus angiography keeps the artery open better than angiography alone. Adults aged 18 or older with CLTI who are having endovascular therapy for a blocked artery below the knee may take part. Participants are assigned by chance to be treated with either both imaging methods or angiography alone, and are followed for 12 months. The main question is how well the treated artery stays open at 6 months; researchers will also compare repeat procedures, amputation, complications, wound healing, survival, and quality of life.

Conditions

• Chronic Limb-Threatening Ischemia

Interventions

PROCEDURE

Intravascular ultrasound-guided EVT

Endovascular therapy of the below-the-knee artery is guided by intravascular ultrasound (IVUS) imaging in addition to X-ray angiography, with IVUS used to assess the lesion, size and select devices, optimize treatment, and confirm the final result.

PROCEDURE

Angiography-guided EVT

Endovascular therapy of the below-the-knee artery is guided by X-ray angiography with contrast dye alone, without the use of intravascular ultrasound, to assess the lesion, size and select devices, and judge the final result.

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Chi Mei Medical Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Shin Kong Wu Ho-Su Memorial Hospital

  lead OTHER

Principal Investigators

• Donna SH Lin, MD · Shin Kong Wu Ho-Su Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2030-07-31

Completion

2030-07-31

Countries

• Taiwan

Study Locations