MedTrace Logo

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

NCT06939374 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Intracoronary Cryotherapy

Intracoronary cryotherapy for stabilization of High-risk coronary plaque

Sponsors & Collaborators

  • CoreAalst BV

    collaborator INDUSTRY

  • Cryotherapeutics SA

    lead INDUSTRY

Principal Investigators

  • Carlos Collet, MD · Cardiovascular Research Foundation, New York, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • Belgium
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939374 on ClinicalTrials.gov