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

NCT06939374 | Not Yet Recruiting DMC

• 1 other identifier: CT-CP-P01_0104
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Medical device; traditional feasibility; Single Group; Device Feasibility; Multi-Center; Prospective; Interventional

Outcome Measures

Primary Outcomes (1)

• Change in MaxLCBI4mm

  Reduction of at least 30% in maxLCBI4mm in the lesion measured by NIRS

  At 9 months post-CTS procedure compared to baseline.

Secondary Outcomes (15)

• Change in Fibrous Cap Thickness

  At 9 months post-CTS procedure compared to baseline

• Change in Minimal Lumen Area (MLA)

  At 9 months post-CTS procedure compared to baseline.

• Prevalence of Thin Cap Fibrous Atheroma

  At 9 months post-CTS procedure compared to baseline.

• Prevalence of lipid Arc >90°

  At 9 months post-CTS procedure compared to baseline.

• Prevalence of lipid Arc >180°

  At 9 months post-CTS procedure compared to baseline.

Study Arms (1)

Treatment arm

EXPERIMENTAL

Subjects with coronary HRP lesions treated with intracoronary cryotherapy using the CTS device

Device: Intracoronary Cryotherapy

Interventions

Intracoronary Cryotherapy DEVICE

Intracoronary cryotherapy for stabilization of High-risk coronary plaque

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Subject is at least 18 years old. 2) Subject has acute cardiac pain/angina consistent with stable angina or acute coronary syndrome eligible for coronary angiography meeting one of the following criteria:
• Non-ST-segment elevation myocardial infarction (NSTEMI) with rise/fall of cardiac enzymes (troponin I or T) with at least one value above the 99th percentile of the upper reference limit requiring PCI within 72 hours from diagnosis
• Unstable angina
• ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion.
• NOTE: subjects with unstable angina, for whom the culprit lesion as assessed by investigator does not require PCI currently or within the next 6 months (subject treated with optimal medical treatment) can be enrolled in the study.
• \) Subject has at least one high-risk plaque meeting the criteria below:
• Located in a non-culprit vessel,
• High-risk plaque lesion on CCTA and at least one of the following features:
• Presence of low-attenuation plaque (HU\<50) and/or
• Positive remodelling (remodelling index \>1.1) and/or
• Napkin ring sign and/or
• Plaque burden ≥70%
• Lesion length ≤ 20 mm.
• Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\>0.80 or NHPR\>0.89).
• Reference vessel diameter (RVD) \< 3.75 mm and \> 2.50 mm in diameter

You may not qualify if:

• \) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).
• \) Subject has ongoing ST-segment elevation myocardial infarction. 3) Subject had a procedural complication during the ACS PCI procedure. 4) Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.
• \) Subject has known reduced Left Ventricular Ejection Fraction \< 30%. 6) Subject has known severe valvular heart disease. 7) Subject has known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2). 8) Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months.
• \) Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.
• \) Subject has severe peripheral vascular disease impeding femoral artery access.
• \) Subject is pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or is a female with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).
• Visible distal embolization/no-reflow following culprit lesions PCI.
• Left main coronary artery disease (visual diameter stenosis \> 50%).
• Stent thrombosis/restenosis as a culprit lesion.
• CTS lesion involving a bifurcation (defined as lesions involving side branches \>2.0 mm).
• Angiographic or CCTA evidence of severe calcification and/or marked tortuosity of the index vessel and/or lesion.
• Thrombotic lesions.
• Ostial lesions.

Sponsors & Collaborators

• Cryotherapeutics SA: lead
• CoreAalst BV: collaborator

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Collet, MD

  AZORG Hospital, Aalst, belgium

  STUDY CHAIR

Central Study Contacts

Danny Detiege, RN

CONTACT

+32 467 02 47 73; dde@cryotherapeutics.com

Elisa Rossetti, MSc, Biomedical engineering

CONTACT

+3242644773; ero@cryotherapeutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Multi-Center, Interventional, Device Feasibility

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share