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ICECAPNCT06939374

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 11 months later.

See at-risk trials from Cryotherapeutics SA

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 31, 2027 to Dec 31, 2027 Show 5 more changesShow less
    • Start date: Mar 1, 2025 to Mar 1, 2026
    • Study completion pushed from Jun 30, 2027 to Apr 30, 2028
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 4 of 15 entries
    • Site details revised at 1 of 3 sites
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 25 to 30
    • Study sites: 0 to 3
    • Start date changed from estimate of Jun 1, 2025 to Mar 1, 2025
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Primary efficacy endpoint
Timeframe: At 9 months post-CTS procedure compared to baseline.
co-primary safety endpoint
Timeframe: at 30 days post procedure

Secondary (15)

Change in Fibrous Cap Thickness
Change in Minimal Lumen Area (MLA)
Prevalence of Thin Cap Fibrous Atheroma
Prevalence of lipid Arc >90°
Prevalence of lipid Arc >180°
Show 10 moreShow less
Prevalence of lipid Arc >270°
Total angle of macrophage
Maximum angle of macrophage
Total angle of lipidic plaque
Maximum angle of lipidic plaque
Total angle of calcification
Maximum angle of calcification
Total Plaque volume
Calcified Plaque volume
Area stenosis

Arms and interventions

Treatment armExperimental

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

Devices: Intracoronary Cryotherapy

Sites

3 sites in 2 countries

United Kingdom 2, Belgium 1