NCT06939374

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

Clinical Investigation of the Efficacy and Safety of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cryotherapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with symptomatic coronary artery disease, successfully treated for their culprit lesion and with presence of at least one HRP lesion in another vessel. Eligible patients will undergo cryotherapy during a planned procedure. Near-infrared spectrometry (NIRS and Optical Coherence Tomography imaging will be used during baseline procedure, and during a 9 months follow visit. The primary endpoint is reduction of plaque burden measured as 30% reduction in maxLCBI4mm as measured by NIRS at 9 months post procedure.

Detailed description

ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with stable angina or Acute Coronary Syndrome (ACS). Patients who have undergone successful treatment of their culprit lesion, and in whom presence of at least one non-flow-limiting HRP lesion in another vessel is identified (confirmed by Coronary Computed Tomography Angiography - CCTA), are eligible for the study. Eligible patients will undergo cryotherapy using the CTS during a planned procedure within maximum 8 weeks after eligibility has been confirmed. Near-infrared spectrometry (NIRS) and Optical Coherence Tomography (OCT) imaging will be used during baseline procedure, and during a 9 months angiographic follow visit. Clinical follow-up visits will be done at 1, 3, 6, 9 and 12 months post-procedure. The primary endpoint is reduction of plaque burden, defined as 30% reduction in maxLCBI4mm measured by NIRS at 9 months post procedure. Secondary efficacy endpoints include: changes in fibrous cap thickness assessed by OCT at 9 months post-procedure, changes in Plaque volume and plaque composition at 9 months post-procedure. Safety endpoints include procedural success rates, any cryotherapy related complication or any Major Adverse Cardiac Event (MACE) at 3 and 12 months post procedure. The enrolment period is expected to last 9 months, and all subjects will be followed for 12 months after the CTS procedure.

Conditions

• Coronary Arterial Disease (CAD)
• Plaque
• Vulnerable Plaque
• Cryotherapy
• Cryotherapy Effect
• Coronary Balloon
• Atherosclerosis Coronary Artery With Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Intracoronary Cryotherapy	Intracoronary cryotherapy for stabilization of High-risk coronary plaque

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-01-31
• Completion: 2027-06-30
• First posted: 2025-04-22
• Last updated: 2026-04-06

Locations

3 sites across 2 countries: Belgium, United Kingdom