Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

NCT06369142 · tracked via the Priya Life Science Germany tracker

Sponsor

Deutsches Herzzentrum Muenchen

Phase

Not applicable

Started

2024-07-01

Last updated

2026-01-06

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Intravascular lithotripsy (IVL)Standard non-IVL methods

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

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. age ≥18 years and able to give informed consent 2. written informed consent to participate in the clinical trial 3. typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy 4. angiographic evidence of coronary artery disease 5. de novo lesion in a native coronary artery 6. target vessel diameter 2.5-4 mm 7. severe calcification of the target lesion (angiographic grade 3) Exclusion Criteria: 1. myocardial infarction \<1 week 2. thrombus in the target vessel 3. life expectancy due to other disease \<1 year 4. simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed 5. pregnancy (current, suspected, planned) or positive pregnancy test

Primary outcome measure(s)

Combined endpoint of major cardiac and cerebrovascular events — 12 months after randomization
all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel

Trial sites (22)

Facility	City	Region	Status
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie	Heidelberg	Baden-Wurttemberg	Active Not Recruiting
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin	Mannheim	Baden-Wurttemberg	Recruiting
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)	Singen	Baden-Wurttemberg	Recruiting
Cardiologikum Herzklinik Ulm MVZ	Ulm	Baden-Wurttemberg	Active Not Recruiting
Universitätsklinikum Ulm	Ulm	Baden-Wurttemberg	Recruiting
Universitätsklinikum Augsburg A.ö.R.	Augsburg	Bavaria	Recruiting
Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie	Dachau	Bavaria	Recruiting
Klinikum Landkreis Erding	Erding	Bavaria	Recruiting
Klinikum Ingolstadt	Ingolstadt	Bavaria	Recruiting
Deutsches Herzzentrum München	Munich	Bavaria	Recruiting
Klinikum der Ludwig-Maximilians-Universität München	München	Bavaria	Not Yet Recruiting
Augustinum Klinik München	München	Bavaria	Recruiting
Universitäres Herz- und Gefäßzentrum	Hamburg	Free and Hanseatic City of Hamburg	Recruiting
Krankenhaus Landshut-Achdorf, LAKUMED Kliniken	Landshut	Germany	Recruiting
Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung	Rotenburg an der Fulda	Hesse	Recruiting
Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen	North Rhine-Westphalia	Recruiting
Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum	Essen	North Rhine-Westphalia	Recruiting
Krankenhaus Barmherzige Brüder Trier	Trier	Rhineland-Palatinate	Recruiting
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden	Dresden	Saxony	Active Not Recruiting
Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin	Bad Oldesloe	Schleswig-Holstein	Recruiting
Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité	Berlin	State of Berlin	Recruiting
BG Klinikum Unfallkrankenhaus Berlin gGmbH	Berlin	State of Berlin	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06369142 on ClinicalTrials.gov ↗ ← All trials in Germany