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NCT05016726: ROLLING-STONE

Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions

Status unknown Last updated 23 August 2021
What this trial tests

trial testing Intravascular Lithotripsy in Coronary Artery Disease in 400 participants. Status unknown.

Timeline
1 October 2021
Primary endpoint
1 October 2023
30 October 2024

Quick facts

Lead sponsorSS Annunziata Hospital, Savigliano
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment400
Start date1 October 2021
Primary completion1 October 2023
Estimated completion30 October 2024

Drugs / interventions tested

Conditions studied

Sponsor

SS Annunziata Hospital, Savigliano

Who can join

18 and older, any sex, with Coronary Artery Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions.
    Riley RF, Patel MP, Abbott JD, Bangalore S, et al · · 2024 · cited 58× · PMID 39132214 · DOI 10.1016/j.jscai.2023.101259
  2. The Significance of Coronary Artery Calcification for Percutaneous Coronary Interventions.
    Lis P, Rajzer M, Klima Ł. · · 2024 · cited 1× · PMID 38470631 · DOI 10.3390/healthcare12050520
  3. Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries: Multicenter, Prospective ROLLING STONE Study.
    Cerrato E, Pavani M, Zecchino S, Leoncini M, et al · · 2026 · PMID 41609534 · DOI 10.1016/j.jcin.2025.11.033

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Other trials of Intravascular Lithotripsy

Trials testing the same drug.

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05016726.

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