Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy (ISAR-WAVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Intravascular lithotripsy (IVL); Device: Standard non-IVL methods

• Study Type: Interventional
• Enrollment (Estimated): 666
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Cassese, MD, PHD; Phone Number: 2764 +49891218; Email: cassese@dhm.mhn.de
• Study Contact Backup: Name: Thorsten Kessler, MD; Phone Number: 2786 +49891218; Email: thorsten.kessler@tum.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Active, not recruiting
      • Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Recruiting
      • Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
      • Contact: Ibrahim Akin, Prof. Dr. med.; Phone Number: +49-621-383 2512; Email: ibrahim.akin@umm.de
      • Principal Investigator: Ibrahim Akin, Prof. Dr. med.
    • Singen, Baden-Wurttemberg, Germany, 78224
      • Recruiting
      • Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
      • Contact: Marc Kollum, PD Dr. med.; Phone Number: +49-7731-89 2600; Email: marc.kollum@glkn.de
      • Principal Investigator: Marc Kollum, PD Dr. med.
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Recruiting
      • Universitatsklinikum Ulm
      • Contact: Wolfgang Rottbauer, Prof. Dr. med.; Phone Number: +49 731 500 45001; Email: sekretariat.rottbauer@uniklinik- ulm.de
    • Ulm, Baden-Wurttemberg, Germany, 89077
      • Active, not recruiting
      • Cardiologikum Herzklinik Ulm MVZ
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • Universitätsklinikum Augsburg A.ö.R.
      • Contact: Dario Bongiovanni, Prof. Dr. med., PhD; Phone Number: +49 821 400 165 824; Email: dario.bongiovanni@uk-augsburg.de
    • Dachau, Bavaria, Germany, 85221
      • Recruiting
      • Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
      • Contact: Bernhard Witzenbichler, PD Dr. med.; Phone Number: +49-8131-76 228; Email: bernhard.witzenbichler@helios-gesundheit.de
      • Principal Investigator: Bernhard Witzenbichler, PD Dr. med.
    • Erding, Bavaria, Germany, 85435
      • Recruiting
      • Klinikum Landkreis Erding
      • Contact: Lorenz Bott-Flügel, PD Dr. med.; Phone Number: +49 8122 591760; Email: lorenz.bott-fluegel@klinikum-erding.de
      • Principal Investigator: Lorenz Bott-Flügel, PD Dr. med.
    • Ingolstadt, Bavaria, Germany, 85049
      • Recruiting
      • Klinikum Ingolstadt
      • Contact: Blerim Luani, PD Dr. med.; Phone Number: +49 841 8 80-21 00; Email: blerim.luani@klinikum-ingolstadt.de
    • Munich, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum München
      • Principal Investigator: Salvatore Cassese, MD, PDH
      • Contact: Salvatore Cassese, PD, PHD; Phone Number: 2764 +49 89 1218; Email: cassese@dhm.mhn.de
    • München, Bavaria, Germany, 81337
      • Not yet recruiting
      • Klinikum der Ludwig-Maximilians-Universität München
      • Contact: Konstantinos Rizas, Prof. Dr. med.; Phone Number: +49 89 4400 73169; Email: konstantinos.rizas@med.uni-muenchen.de
    • München, Bavaria, Germany, 81375
      • Recruiting
      • Augustinum Klinik München
      • Contact: Oliver Husser, Prof. Dr. med.; Phone Number: +49 89 7097 1154; Email: oliver.husser@med.augustinum.de
  • Germany
    • Landshut, Germany, Germany, 84036
      • Recruiting
      • Krankenhaus Landshut-Achdorf, LAKUMED Kliniken
      • Contact: Julinda Mehilli, Prof. Dr. med.; Phone Number: +49 871 404 2780; Email: julinda.mehilli@lakumed.de
  • Hamburg
    • Hamburg, Hamburg, Germany, 20246
      • Recruiting
      • Universitäres Herz- und Gefäßzentrum
      • Contact: Fabian Brunner, PD Dr. med.; Phone Number: +49 40 7410-53979; Email: fa.brunner@uke.de
  • Hesse
    • Rotenburg an der Fulda, Hesse, Germany, 36199
      • Recruiting
      • Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
      • Contact: Marcus Franz, Prof. Dr. med.; Phone Number: +49-6623-88 60 10; Email: M.Franz@hkz-rotenburg.de
      • Principal Investigator: Marcus Franz, Prof. Dr. med.
  • North Rhine-Westphalia
    • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
      • Recruiting
      • Herz- und Diabeteszentrum Nordrhein-Westfalen
      • Contact: Mohamed Ayoub, Dr. med.; Phone Number: +49 5731 97-1276; Email: mayoub@hdz-nrw.de
    • Essen, North Rhine-Westphalia, Germany, 45138
      • Recruiting
      • Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
      • Contact: Tobias Weinreich, Dr. med.; Phone Number: +49-201-897 3200; Email: t.weinreich@contilia.de
      • Principal Investigator: Tobias Weinreich, Dr. med.
  • Rhineland-Palatinate
    • Trier, Rhineland-Palatinate, Germany, 54292
      • Recruiting
      • Krankenhaus Barmherzige Brüder Trier
      • Contact: Nikos Werner, Prof. Dr. med.; Phone Number: +49 651 208 2784; Email: n.werner@bbtgruppe.de
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Active, not recruiting
      • Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
  • Schleswig-Holstein
    • Bad Oldesloe, Schleswig-Holstein, Germany, 23843
      • Recruiting
      • Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
      • Contact: Ralph Tölg, PD Dr. med.; Phone Number: +49-4531-682405; Email: r.toelg@asklepios.com
      • Principal Investigator: Ralph Tölg, PD Dr. med.
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Recruiting
      • Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
      • Principal Investigator: Anna Brand, PD Dr. med.
      • Contact: Damaris Praeger, Dr. med.; Phone Number: +49 30 450 513 359; Email: Damaris.praeger@dhzc-charite.de
    • Berlin, State of Berlin, Germany, 12683
      • Recruiting
      • BG Klinikum Unfallkrankenhaus Berlin gGmbH
      • Contact: Johannes Beil, Dr. med.; Phone Number: +49 30 5681 - 3641; Email: Johannes.beil@ukb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lesion preparation using coronary intravascular lithotripsy	Device: Intravascular lithotripsy (IVL); Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Active Comparator: Lesion preparation using other methods than intravascular lithotripsy; e.g. cutting or super high pressure balloons and/or ablative procedures	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Definite stent thrombosis	12 months after randomization
Clinically indicated non-target vessel revascularization	12 months after randomization
Hospitalization due to acute coronary syndrome	12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status	12 months after randomization
Symptoms of CHD: mental health status	12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)	30 days after randomization
Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure)	12 months after randomization
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)	12 months after randomization

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Technical University of Munich; EvidentIQ Germany GmbH; Gemeinsamer Bundesaussschuss; Monitoring Services GmbH
• Investigators: Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Stent; Coronary Artery Disease; Percutaneous Coronary Intervention; Intravascular Lithotripsy; Calcified lesion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: GE IDE No. L00123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No