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RECRUITING
NCT06369142
NA

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Sponsor: Deutsches Herzzentrum Muenchen

View on ClinicalTrials.gov

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.

Official title: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

666

Start Date

2024-07-01

Completion Date

2027-07-31

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

DEVICE

Intravascular lithotripsy (IVL)

Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm

DEVICE

Standard non-IVL methods

Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures

Locations (22)

Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin

Mannheim, Baden-Wurttemberg, Germany

Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)

Singen, Baden-Wurttemberg, Germany

Cardiologikum Herzklinik Ulm MVZ

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Augsburg A.ö.R.

Augsburg, Bavaria, Germany

Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie

Dachau, Bavaria, Germany

Klinikum Landkreis Erding

Erding, Bavaria, Germany

Klinikum Ingolstadt

Ingolstadt, Bavaria, Germany

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, Germany

Augustinum Klinik München

München, Bavaria, Germany

Krankenhaus Landshut-Achdorf, LAKUMED Kliniken

Landshut, Germany, Germany

Universitäres Herz- und Gefäßzentrum

Hamburg, Hamburg, Germany

Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung

Rotenburg an der Fulda, Hesse, Germany

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum

Essen, North Rhine-Westphalia, Germany

Krankenhaus Barmherzige Brüder Trier

Trier, Rhineland-Palatinate, Germany

Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

Dresden, Saxony, Germany

Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin

Bad Oldesloe, Schleswig-Holstein, Germany

Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité

Berlin, State of Berlin, Germany

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, State of Berlin, Germany