Last reviewed · How we verify
NCT05016726: ROLLING-STONE
Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions
trial testing Intravascular Lithotripsy in Coronary Artery Disease in 400 participants. Status unknown.
1 October 2023
Quick facts
| Lead sponsor | SS Annunziata Hospital, Savigliano |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 October 2021 |
| Primary completion | 1 October 2023 |
| Estimated completion | 30 October 2024 |
Drugs / interventions tested
- Intravascular Lithotripsy
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Myocardial Infarction — all drugs for Myocardial Infarction →
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):
-
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT05016726
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Intravascular Lithotripsy
Trials testing the same drug.
- NCT07109479 — Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intrava · NA · not yet recruiting
- NCT06238518 — Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions · NA · unknown
- NCT06089135 — Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Tria · NA · completed
- NCT05858905 — FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter · NA · completed
- NCT05662787 — BOLT Lithotripsy RESTORE ATK Trial · NA · completed
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05016726 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SS Annunziata Hospital, Savigliano
- Last refreshed: 23 August 2021
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing