Coronary Artery DiseaseISAR-WAVENCT06369142
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
A study testing Intravascular lithotripsy (IVL) and Standard non-IVL methods in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 22 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intravascular lithotripsy (IVL) and Standard non-IVL methods
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 22 sitesGermany
- Study dates
- 1 Jul 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
Germany22 sites, 19 recruiting
- Recruiting
Universitätsklinikum Augsburg A.ö.R.
Augsburg, Bavaria, 86156
Dario Bongiovanni, Prof. Dr. med., PhD, +49 821 400 165 824, dario.bongiovanni@uk-augsburg.de
- Recruiting
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, 32545
Mohamed Ayoub, Dr. med., +49 5731 97-1276, mayoub@hdz-nrw.de
- Recruiting
Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
Bad Oldesloe, Schleswig-Holstein, 23843
Ralph Tölg, PD Dr. med., +49-4531-682405, r.toelg@asklepios.com
Ralph Tölg, PD Dr. med.
- Recruiting
Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 10117
Damaris Praeger, Dr. med., +49 30 450 513 359, Damaris.praeger@dhzc-charite.de
Anna Brand, PD Dr. med.
- Recruiting
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, State of Berlin, 12683
Johannes Beil, Dr. med., +49 30 5681 - 3641, Johannes.beil@ukb.de
- Recruiting
Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
Dachau, Bavaria, 85221
Bernhard Witzenbichler, PD Dr. med., +49-8131-76 228, bernhard.witzenbichler@helios-gesundheit.de
Bernhard Witzenbichler, PD Dr. med.
- Active, not recruiting
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony, 01307
- Recruiting
Klinikum Landkreis Erding
Erding, Bavaria, 85435
Lorenz Bott-Flügel, PD Dr. med., +49 8122 591760, lorenz.bott-fluegel@klinikum-erding.de
Lorenz Bott-Flügel, PD Dr. med.
- Recruiting
Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
Essen, North Rhine-Westphalia, 45138
Tobias Weinreich, Dr. med., +49-201-897 3200, t.weinreich@contilia.de
Tobias Weinreich, Dr. med.
- Recruiting
Universitäres Herz- und Gefäßzentrum
Hamburg, Free and Hanseatic City of Hamburg, 20246
Fabian Brunner, PD Dr. med., +49 40 7410-53979, fa.brunner@uke.de
- Active, not recruiting
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
Klinikum Ingolstadt
Ingolstadt, Bavaria, 85049
Blerim Luani, PD Dr. med., +49 841 8 80-21 00, blerim.luani@klinikum-ingolstadt.de
- Recruiting
Krankenhaus Landshut-Achdorf, LAKUMED Kliniken
Landshut, Germany, 84036
Julinda Mehilli, Prof. Dr. med., +49 871 404 2780, julinda.mehilli@lakumed.de
- Recruiting
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
Mannheim, Baden-Wurttemberg, 68167
Ibrahim Akin, Prof. Dr. med., +49-621-383 2512, ibrahim.akin@umm.de
Ibrahim Akin, Prof. Dr. med.
- Not yet recruiting
Klinikum der Ludwig-Maximilians-Universität München
München, Bavaria, 81337
Konstantinos Rizas, Prof. Dr. med., +49 89 4400 73169, konstantinos.rizas@med.uni-muenchen.de
- Recruiting
Augustinum Klinik München
München, Bavaria, 81375
Oliver Husser, Prof. Dr. med., +49 89 7097 1154, oliver.husser@med.augustinum.de
- Recruiting
Deutsches Herzzentrum München
Munich, Bavaria, 80636
Salvatore Cassese, PD, PHD, +49 89 1218 ext. 2764, cassese@dhm.mhn.de
Salvatore Cassese, MD, PDH
- Recruiting
Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
Rotenburg an der Fulda, Hesse, 36199
Marcus Franz, Prof. Dr. med., +49-6623-88 60 10, M.Franz@hkz-rotenburg.de
Marcus Franz, Prof. Dr. med.
- Recruiting
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
Singen, Baden-Wurttemberg, 78224
Marc Kollum, PD Dr. med., +49-7731-89 2600, marc.kollum@glkn.de
Marc Kollum, PD Dr. med.
- Recruiting
Krankenhaus Barmherzige Brüder Trier
Trier, Rhineland-Palatinate, 54292
Nikos Werner, Prof. Dr. med., +49 651 208 2784, n.werner@bbtgruppe.de
- Active, not recruiting
Cardiologikum Herzklinik Ulm MVZ
Ulm, Baden-Wurttemberg, 89077
- Recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Wolfgang Rottbauer, Prof. Dr. med., +49 731 500 45001, sekretariat.rottbauer@uniklinik- ulm.de
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Intravascular lithotripsy (IVL), Standard non-IVL methods
- Keywords
- Coronary Artery Disease, Calcified lesion, Percutaneous Coronary Intervention, Stent, Intravascular Lithotripsy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular lithotripsy (IVL)Device
Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Standard non-IVL methodsDevice
Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures
| Study group | Role | What they receive |
|---|---|---|
| Lesion preparation using coronary intravascular lithotripsy | Experimental | Not described Receives: 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 Receives: Device: Standard non-IVL methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after randomization
Secondary outcomes (13)
Mortality
Measured: 12 months after randomization
Cardiac mortality
Measured: 12 months after randomization
Non-fatal myocardial infarction
Measured: 12 months after randomization
Non-fatal stroke
Measured: 12 months after randomization
Clinically indicated target vessel revascularization
Measured: 12 months after randomization
Definite stent thrombosis
Measured: 12 months after randomization
Clinically indicated non-target vessel revascularization
Measured: 12 months after randomization
Hospitalization due to acute coronary syndrome
Measured: 12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status
Measured: 12 months after randomization
Symptoms of CHD: mental health status
Measured: 12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)
Measured: 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)
Measured: 12 months after randomization
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jul 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss, EvidentIQ Germany GmbH, Monitoring Services GmbH, Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Adnan Kastrati, MD, Study chair, Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369142
- Sponsor's protocol ID
- GE IDE No. L00123
- Acronym
- ISAR-WAVE
- Status last verified
- Jan 2025
- First submitted
- 12 Apr 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39710352
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy
- ClinicalTrials.gov ID
- NCT06369142
- Acronym / sponsor ID
- ISAR-WAVE / GE IDE No. L00123
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Calcified lesion, Percutaneous Coronary Intervention, Stent, Intravascular Lithotripsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 666 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss, EvidentIQ Germany GmbH, Monitoring Services GmbH, Technical University of Munich
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lesion preparation using coronary intravascular lithotripsy | Experimental | Device: Intravascular lithotripsy (IVL) |
| Lesion preparation using other methods than intravascular lithotripsy | Active comparator | Device: Standard non-IVL methodse.g. cutting or super high pressure balloons and/or ablative procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular lithotripsy (IVL)Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm | Device | Lesion preparation using coronary intravascular lithotripsy |
| Standard non-IVL methodsStandard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures | Device | Lesion preparation using other methods than intravascular lithotripsy |
Primary outcome
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
13 secondary outcomes
Mortality
Time frame: 12 months after randomization
Cardiac mortality
Time frame: 12 months after randomization
Non-fatal myocardial infarction
Time frame: 12 months after randomization
Non-fatal stroke
Time frame: 12 months after randomization
Clinically indicated target vessel revascularization
Time frame: 12 months after randomization
Definite stent thrombosis
Time frame: 12 months after randomization
Clinically indicated non-target vessel revascularization
Time frame: 12 months after randomization
Hospitalization due to acute coronary syndrome
Time frame: 12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status
Time frame: 12 months after randomization
Symptoms of CHD: mental health status
Time frame: 12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)
Time frame: 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
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 39710352Cassese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adnan Kastrati, MD study chair
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy (IVL) and Standard non-IVL methods in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 22 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Cassese, MD, PHD (+49891218 ext. 2764, cassese@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of major cardiac and cerebrovascular events (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.