Clinical Trial

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Study acronym: ISAR-WAVE
Recruiting
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-04-12; most recent amendment 2026-01-05.
Status change: Not Yet Recruiting → Recruiting 2024-09-06
Trial Details
NCT Number NCT06369142
Lead Sponsor Deutsches Herzzentrum Muenchen
Collaborators: Gemeinsamer Bundesaussschuss, EvidentIQ Germany GmbH, Monitoring Services GmbH, Technical University of Munich
Conditions Coronary Artery Disease
Enrollment 666 participants
Start Date 2024-07-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-06