Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• age ≥18 years and able to give informed consent
• written informed consent to participate in the clinical trial
• typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
• angiographic evidence of coronary artery disease
• de novo lesion in a native coronary artery
• target vessel diameter 2.5-4 mm
• severe calcification of the target lesion (angiographic grade 3)
Locations
Other Locations
Germany
Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
RECRUITING
Bad Oldesloe
Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
RECRUITING
Berlin
Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
ACTIVE_NOT_RECRUITING
Dachau
Klinikum Landkreis Erding
RECRUITING
Erding
Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
RECRUITING
Essen
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
ACTIVE_NOT_RECRUITING
Heidelberg
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
RECRUITING
Mannheim
Deutsches Herzzentrum München
RECRUITING
Munich
Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
RECRUITING
Rotenburg A.d.f.
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
ACTIVE_NOT_RECRUITING
Singen
Contact Information
Primary
Salvatore Cassese, MD, PHD
cassese@dhm.mhn.de
+49891218
Backup
Thorsten Kessler, MD
thorsten.kessler@tum.de
+49891218
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 666
Treatments
Experimental: Lesion preparation using coronary intravascular lithotripsy
Active_comparator: Lesion preparation using other methods than intravascular lithotripsy
e.g. cutting or super high pressure balloons and/or ablative procedures
Related Therapeutic Areas
Sponsors
Collaborators: EvidentIQ Germany GmbH, Gemeinsamer Bundesaussschuss, Technical University of Munich, Monitoring Services GmbH
Leads: Deutsches Herzzentrum Muenchen