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Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

Study acronym: NODULE-SHOCK
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Primary completion date changed from estimate of Dec 31, 2026 to Aug 11, 2026 · Completion moved earlier from Dec 31, 2027 to Aug 11, 2027 · Eligibility criteria expanded, about 24 words · 3 more Show 6 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2026 to Aug 11, 2026
    • Completion moved earlier from Dec 31, 2027 to Aug 11, 2027
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised
    • Study description expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2025 to Oct 6, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2025 to Oct 6, 2025
    • Site details revised
  4. Start date: Aug 2025 to Sep 2025 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).
Trial Details
NCT Number NCT07000045
Lead Sponsor Annapoorna Kini
Conditions Coronary Artery Disease, Coronary Calcification
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov