Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

NCT06369142 | Recruiting DMC

• 1 other identifier: GE IDE No. L00123
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Calcified lesion; Percutaneous Coronary Intervention; Stent; Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of major cardiac and cerebrovascular events

  all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel

  12 months after randomization

Secondary Outcomes (13)

• Mortality

  12 months after randomization

• Cardiac mortality

  12 months after randomization

• Non-fatal myocardial infarction

  12 months after randomization

• Non-fatal stroke

  12 months after randomization

• Clinically indicated target vessel revascularization

  12 months after randomization

Study Arms (2)

Lesion preparation using coronary intravascular lithotripsy

EXPERIMENTAL

Device: Intravascular lithotripsy (IVL)

Lesion preparation using other methods than intravascular lithotripsy

ACTIVE COMPARATOR

e.g. cutting or super high pressure balloons and/or ablative procedures

Device: Standard non-IVL methods

Interventions

Intravascular lithotripsy (IVL) DEVICE

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

Lesion preparation using coronary intravascular lithotripsy

Standard non-IVL methods DEVICE

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

Lesion preparation using other methods than intravascular lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• myocardial infarction \<1 week
• thrombus in the target vessel
• life expectancy due to other disease \<1 year
• simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
• pregnancy (current, suspected, planned) or positive pregnancy test

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Gemeinsamer Bundesaussschuss: collaborator
• EvidentIQ Germany GmbH: collaborator
• Monitoring Services GmbH: collaborator
• Technical University of Munich: collaborator

Study Sites (22)

Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie

Heidelberg, Baden-Wurttemberg, 69120, Germany

ACTIVE NOT RECRUITING

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

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

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

Singen, Baden-Wurttemberg, 78224, Germany

RECRUITING

Cardiologikum Herzklinik Ulm MVZ

Ulm, Baden-Wurttemberg, 89077, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitätsklinikum Augsburg A.ö.R.

Augsburg, Bavaria, 86156, Germany

RECRUITING

Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie

Dachau, Bavaria, 85221, Germany

RECRUITING

Klinikum Landkreis Erding

Erding, Bavaria, 85435, Germany

RECRUITING

Klinikum Ingolstadt

Ingolstadt, Bavaria, 85049, Germany

RECRUITING

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

RECRUITING

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, 81337, Germany

NOT YET RECRUITING

Augustinum Klinik München

München, Bavaria, 81375, Germany

RECRUITING

Krankenhaus Landshut-Achdorf, LAKUMED Kliniken

Landshut, Germany, 84036, Germany

RECRUITING

Universitäres Herz- und Gefäßzentrum

Hamburg, Hamburg, 20246, Germany

RECRUITING

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

Rotenburg an der Fulda, Hesse, 36199, Germany

RECRUITING

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

RECRUITING

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

Essen, North Rhine-Westphalia, 45138, Germany

RECRUITING

Krankenhaus Barmherzige Brüder Trier

Trier, Rhineland-Palatinate, 54292, Germany

RECRUITING

Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

ACTIVE NOT RECRUITING

Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin

Bad Oldesloe, Schleswig-Holstein, 23843, Germany

RECRUITING

Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 10117, Germany

RECRUITING

BG Klinikum Unfallkrankenhaus Berlin gGmbH

Berlin, State of Berlin, 12683, Germany

RECRUITING

Related Publications (1)

• Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20.

  PMID: 39710352 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Adnan Kastrati, MD

  Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

  STUDY CHAIR

Central Study Contacts

Salvatore Cassese, MD, PHD

CONTACT

+49891218; cassese@dhm.mhn.de

Thorsten Kessler, MD

CONTACT

+49891218; thorsten.kessler@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study participant as well as the follow-up physicians and site personal are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (22)