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

January 5, 2026 updated by: Deutsches Herzzentrum Muenchen

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
666

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • 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:
        • Principal Investigator:
          • Marc Kollum, PD Dr. med.
      • Ulm, Baden-Wurttemberg, Germany, 89081
      • Ulm, Baden-Wurttemberg, Germany, 89077
        • Active, not recruiting
        • Cardiologikum Herzklinik Ulm MVZ
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Recruiting
        • Universitätsklinikum Augsburg A.ö.R.
        • Contact:
      • Dachau, Bavaria, Germany, 85221
        • Recruiting
        • Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
        • Contact:
        • Principal Investigator:
          • Bernhard Witzenbichler, PD Dr. med.
      • Erding, Bavaria, Germany, 85435
        • Recruiting
        • Klinikum Landkreis Erding
        • Contact:
        • Principal Investigator:
          • Lorenz Bott-Flügel, PD Dr. med.
      • Ingolstadt, Bavaria, Germany, 85049
      • Munich, Bavaria, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum München
        • Principal Investigator:
          • Salvatore Cassese, MD, PDH
        • Contact:
      • München, Bavaria, Germany, 81337
        • Not yet recruiting
        • Klinikum der Ludwig-Maximilians-Universität München
        • Contact:
      • München, Bavaria, Germany, 81375
    • Germany
      • Landshut, Germany, Germany, 84036
        • Recruiting
        • Krankenhaus Landshut-Achdorf, LAKUMED Kliniken
        • Contact:
    • 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:
        • Principal Investigator:
          • Marcus Franz, Prof. Dr. med.
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum Nordrhein-Westfalen
        • Contact:
      • Essen, North Rhine-Westphalia, Germany, 45138
        • Recruiting
        • Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
        • Contact:
        • Principal Investigator:
          • Tobias Weinreich, Dr. med.
    • Rhineland-Palatinate
      • Trier, Rhineland-Palatinate, Germany, 54292
        • Recruiting
        • Krankenhaus Barmherzige Brüder Trier
        • Contact:
    • 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:
        • 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:
      • Berlin, State of Berlin, Germany, 12683
        • Recruiting
        • BG Klinikum Unfallkrankenhaus Berlin gGmbH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Combined endpoint of major cardiac and cerebrovascular events
Time Frame: 12 months after randomization
all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel
12 months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mortality
Time Frame: 12 months after randomization
12 months after randomization
Cardiac mortality
Time Frame: 12 months after randomization
12 months after randomization
Non-fatal myocardial infarction
Time Frame: 12 months after randomization
12 months after randomization
Non-fatal stroke
Time Frame: 12 months after randomization
12 months after randomization
Clinically indicated target vessel revascularization
Time Frame: 12 months after randomization
12 months after randomization
Definite stent thrombosis
Time Frame: 12 months after randomization
12 months after randomization
Clinically indicated non-target vessel revascularization
Time Frame: 12 months after randomization
12 months after randomization
Hospitalization due to acute coronary syndrome
Time Frame: 12 months after randomization
12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status
Time Frame: 12 months after randomization
12 months after randomization
Symptoms of CHD: mental health status
Time Frame: 12 months after randomization
12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)
Time Frame: 30 days after randomization
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)
Time Frame: 12 months after randomization
12 months after randomization
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)
Time Frame: 12 months after randomization
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deutsches Herzzentrum Muenchen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Technical University of Munich
EvidentIQ Germany GmbH
Gemeinsamer Bundesaussschuss
Monitoring Services GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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