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NCT06369142: ISAR-WAVE
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
NA trial testing Intravascular lithotripsy (IVL) in Coronary Artery Disease in 666 participants. Currently enrolling.
30 April 2027
Quick facts
| Lead sponsor | Deutsches Herzzentrum Muenchen |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 666 |
| Start date | 1 July 2024 |
| Primary completion | 30 April 2027 |
| Estimated completion | 31 July 2027 |
| Sites | 22 locations across Germany |
Drugs / interventions tested
- Intravascular lithotripsy (IVL)
- Standard non-IVL methods
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Deutsches Herzzentrum Muenchen — full company profile →
Who can join
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial.
Cassese S, Simonetti F, Covarrubias HAA, Janisch M, et al · · 2025 · cited 3× · PMID 39710352 · DOI 10.1016/j.ahj.2024.12.008 -
Percutaneous Coronary Interventions for Calcified Lesions: A Systematic Review with Meta-analyses of Randomised Trials.
Kristensen AT, Faltermeier P, Kamp CB, Jakobsen JC, et al · · 2025 · cited 1× · PMID 41346358 · DOI 10.15420/icr.2025.10
Verify or expand the search:
- PubMed search for NCT06369142
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Intravascular lithotripsy (IVL)
Trials testing the same drug.
- NCT05072730 — ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2 · NA · unknown
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
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- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Deutsches Herzzentrum Muenchen trials
Trials by the same sponsor.
- NCT07344480 — Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM) · recruiting
- NCT06753227 — Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart · enrolling by invitation
- NCT06814574 — Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement · recruiting
- NCT06060912 — LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs · NA · recruiting
- NCT05072730 — ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2 · NA · unknown
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 NCT06369142 (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 Deutsches Herzzentrum Muenchen
- Last refreshed: 6 January 2026
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/NCT06369142.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing