Comparing Pressure Wire-Guided and Angiography-Guided Balloon Angioplasty for Treating Chronic Limb-Threatening Ischemia in Lower Leg Arteries

What this Trial Is About

Researchers are evaluating two methods of guiding balloon angioplasty treatment for patients with chronic limb-threatening ischemia affecting the anterior or posterior tibial arteries. This prospective, single-center randomized controlled trial will compare pressure wire-guided angioplasty to angiography-guided angioplasty. The study aims to determine which method better improves blood flow and wound healing in these patients. Participants will be randomly assigned to one of two groups. In the angiography-guided group, balloon angioplasty will be performed to achieve good blood flow based on imaging results, defined as less than 50% narrowing and no flow-blocking dissection. In the pressure wire-guided group, the procedure will be guided by both imaging and pressure measurements, targeting a pressure gradient below 10 mmHg across the treated lesion using a Pressure Wire device. After treatment, participants will be monitored closely with follow-up visits at 1, 3, and 6 months to assess wound healing and clinical outcomes. The main measure of success is achieving skin perfusion pressure of 50 mmHg or higher within 1 to 3 days after the procedure. The study will also track clinical events during the follow-up period to evaluate the treatment effects over time.

Pressure Wire Guidance for Infrapopliteal Artery Interventions