Study of Intracoronary Cryotherapy Using the CryoTherapy System to Treat High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome

What this Trial Is About

Researchers are investigating the effects of intracoronary cryotherapy on vulnerable or high-risk plaque HRP in patients with stable angina or acute coronary syndrome ACS. This multi-center, prospective, single-arm feasibility study aims to evaluate the safety and effectiveness of the CryoTherapy System CTS in reducing plaque burden in coronary arteries. Eligible patients have already been successfully treated for their main heart artery blockage and have at least one HRP lesion in another vessel identified by imaging. Participants will receive intracoronary cryotherapy using the CTS device during a planned procedure within 8 weeks of confirming eligibility. Imaging techniques like Near-infrared spectrometry NIRS and Optical Coherence Tomography OCT will be performed at baseline and repeated at 9 months to assess changes in plaque characteristics. The study includes follow-up visits at 1, 3, 6, 9, and 12 months after treatment to monitor safety and effectiveness. Secondary outcomes will evaluate changes in fibrous cap thickness, plaque volume, and composition, while safety will be tracked by procedure success and adverse cardiac events. During the study, participants will undergo coronary imaging and clinical evaluations at specified intervals up to one year after the cryotherapy procedure. Researchers will measure plaque burden reduction, with the primary goal being a 30% decrease in maximum lipid core burden index maxLCBI4mm at 9 months. Other assessments include tissue changes within the plaque and overall heart artery health. Safety monitoring will include checking for complications related to the cryotherapy and any major adverse cardiac events up to one year post-procedure.

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study