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POLARSTARNCT05600088

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With (N)STEMI or Unstable Angina

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 10 versions: 8 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Final enrollment: 24 participants (planned 30)
    • Eligibility criteria expanded, about 24 words
  2. Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v9
  3. Primary completion date: May 30, 2025 to Dec 31, 2025
    • Site details revised at 3 of 5 sites
    v8
  4. Primary completion date: Sep 30, 2024 to May 30, 2025v7 Show 5 more changesShow less
    • Study sites: 4 to 5
    • Study completion date: Jul 31, 2025 to Jul 31, 2026
    • Start date: Oct 18, 2022 to May 18, 2022
    • Eligibility criteria revised
    • Study title revised
  5. Enrollment target: 10 to 30
    • Primary completion date: Jun 30, 2023 to Sep 30, 2024
    • Study sites: 1 to 4
    • Study completion date: Jul 31, 2024 to Jul 31, 2025
    v5
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v4
  2. Primary endpoint revised
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (11)
    • Study description expanded, about 5 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety: Rate of Cryotherapy related adverse events
Timeframe: 90 days post-procedure

Secondary (7)

Safety: Rate of Cryotherapy related events
Device success
CTS procedure success
Imaging: CCTA assessed Minimum lumen area (MLA)
Imaging: CCTA assessed area stenosis
Show 2 moreShow less
Imaging: CCTA assessed lesion plaque burden
Imaging: CCTA assessed Total plaque volume

Arms and interventions

CTS Treatment ArmExperimental

active cryotherapy of a single suitable high-risk coronary plaque lesion with CTS device

Devices: CryoTherapy System (CTS)

Sites

5 sites in 2 countries

Lithuania 3, Georgia 2