Actively Recruiting
Clinical Investigation of Intracoronary Cryotherapy Using the CryoTherapy System for High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome
Led by Cryotherapeutics SA · Updated on 2026-04-06
30
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Cryotherapeutics SA
Lead Sponsor
C
CoreAalst BV
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years old.
- Subject has acute cardiac pain/angina consistent with stable angina or acute coronary syndrome.
- Subject has non-ST-segment elevation myocardial infarction (NSTEMI) requiring PCI within 72 hours, unstable angina, or ST-segment elevation myocardial infarction (STEMI).
- Successful PCI of the culprit lesion with less than 30% stenosis and TIMI 3 flow without complications.
- Subject has at least one high-risk plaque located in a non-culprit vessel with specified imaging features.
- Lesion length is 20 mm or less.
- Diameter stenosis on angiography between 30% and 70% or negative physiology assessment.
- Reference vessel diameter between 2.50 mm and 3.75 mm.
- Lesions must be accessible and selected by the investigator if multiple are present.
- maxLCBI4mm in the lesion greater than 324.7.
- Subject is able to provide informed consent.
You will not qualify if you...
- Subject is hemodynamically unstable (e.g., cardiogenic shock, hypotension requiring inotropes, hypoxia needing intubation).
- Subject has ongoing ST-segment elevation myocardial infarction.
- Subject had procedural complications during the ACS PCI procedure.
- Subject has history of or planned coronary artery bypass graft (CABG) within 12 months.
- Known left ventricular ejection fraction less than 30%.
- Known severe valvular heart disease.
- Known severe renal insufficiency (eGFR less than 30 ml/min/1.72 m2).
- Life-threatening conditions or comorbidities with life expectancy under 12 months.
- Currently participating in another clinical investigation without a reached primary endpoint.
- Severe peripheral vascular disease preventing femoral artery access.
- Pregnant, lactating, not surgically sterile, or female with childbearing potential without effective contraception.
- Angiographic exclusion: visible distal embolization, left main coronary artery disease over 50% stenosis, stent thrombosis/restenosis as culprit lesion, lesions involving bifurcation side branches over 2.0 mm, severe calcification or tortuosity, thrombotic lesions, or ostial lesions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 8 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive intracoronary cryotherapy using the CryoTherapy System during a planned procedure to stabilize high-risk coronary plaque.
1 procedure visit (in-person)
Duration - 12 months
Participants attend clinical follow-up visits to monitor safety and efficacy outcomes after the cryotherapy procedure.
Visits at 1, 3, 6, 9, and 12 months post-procedure (5 visits)
Trial Site Locations
Total: 3 locations
1
AZORG Aalst
Aalst, Belgium, 9300
Actively Recruiting
2
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
3
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Not Yet Recruiting
Research Team
D
Danny Detiege, RN
E
Elisa Rossetti, MSc, Biomedical engineering
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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