Impact of Pressure Wire-guidance Versus Angiography-guidance for Infrapopliteal Artery Interventions on Post-procedural Perfusion Status and Wound Healing in Patients With Chronic Limb Threatening Ischemia (PERFECT-CLI)

"• 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."