Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06369142

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Led by Deutsches Herzzentrum Muenchen · Updated on 2026-01-06

666

Participants Needed

22

Research Sites

160 weeks

Total Duration

On this page

Sponsors

D

Deutsches Herzzentrum Muenchen

Lead Sponsor

G

Gemeinsamer Bundesaussschuss

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older 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 between 2.5 and 4 mm
  • Severe calcification of the target lesion (angiographic grade 3)
Not Eligible

You will not qualify if you...

  • Myocardial infarction less than 1 week ago
  • Thrombus in the target vessel
  • Life expectancy less than 1 year due to other diseases
  • Simultaneous participation in an ongoing clinical trial with medical devices or medicinal products
  • Current, suspected, or planned pregnancy or positive pregnancy test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie

Heidelberg, Baden-Wurttemberg, Germany, 69120

Active, Not Recruiting

2

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

Mannheim, Baden-Wurttemberg, Germany, 68167

Actively Recruiting

3

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

Singen, Baden-Wurttemberg, Germany, 78224

Actively Recruiting

4

Cardiologikum Herzklinik Ulm MVZ

Ulm, Baden-Wurttemberg, Germany, 89077

Active, Not Recruiting

5

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

6

Universitätsklinikum Augsburg A.ö.R.

Augsburg, Bavaria, Germany, 86156

Actively Recruiting

7

Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie

Dachau, Bavaria, Germany, 85221

Actively Recruiting

8

Klinikum Landkreis Erding

Erding, Bavaria, Germany, 85435

Actively Recruiting

9

Klinikum Ingolstadt

Ingolstadt, Bavaria, Germany, 85049

Actively Recruiting

10

Deutsches Herzzentrum München

Munich, Bavaria, Germany, 80636

Actively Recruiting

11

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, Germany, 81337

Not Yet Recruiting

12

Augustinum Klinik München

München, Bavaria, Germany, 81375

Actively Recruiting

13

Universitäres Herz- und Gefäßzentrum

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246

Actively Recruiting

14

Krankenhaus Landshut-Achdorf, LAKUMED Kliniken

Landshut, Germany, Germany, 84036

Actively Recruiting

15

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

Rotenburg an der Fulda, Hesse, Germany, 36199

Actively Recruiting

16

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545

Actively Recruiting

17

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

Essen, North Rhine-Westphalia, Germany, 45138

Actively Recruiting

18

Krankenhaus Barmherzige Brüder Trier

Trier, Rhineland-Palatinate, Germany, 54292

Actively Recruiting

19

Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

Dresden, Saxony, Germany, 01307

Active, Not Recruiting

20

Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin

Bad Oldesloe, Schleswig-Holstein, Germany, 23843

Actively Recruiting

21

Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

22

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, State of Berlin, Germany, 12683

Actively Recruiting

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Research Team

S

Salvatore Cassese, MD, PHD

CONTACT

T

Thorsten Kessler, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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