Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
NCT ID: NCT06369142
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
666 participants
INTERVENTIONAL
2024-07-01
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lesion preparation using coronary intravascular lithotripsy
Intravascular lithotripsy (IVL)
Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Lesion preparation using other methods than intravascular lithotripsy
e.g. cutting or super high pressure balloons and/or ablative procedures
Standard non-IVL methods
Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures
Interventions
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Intravascular lithotripsy (IVL)
Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Standard non-IVL methods
Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Gemeinsamer Bundesaussschuss
UNKNOWN
EvidentIQ Germany GmbH
UNKNOWN
Monitoring Services GmbH
UNKNOWN
Technical University of Munich
OTHER
Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Principal Investigators
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Adnan Kastrati, MD
Role: STUDY_CHAIR
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Locations
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Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
Mannheim, Baden-Wurttemberg, Germany
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
Singen, Baden-Wurttemberg, Germany
Cardiologikum Herzklinik Ulm MVZ
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Augsburg A.ö.R.
Augsburg, Bavaria, Germany
Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
Dachau, Bavaria, Germany
Klinikum Landkreis Erding
Erding, Bavaria, Germany
Klinikum Ingolstadt
Ingolstadt, Bavaria, Germany
Deutsches Herzzentrum München
Munich, Bavaria, Germany
Klinikum der Ludwig-Maximilians-Universität München
München, Bavaria, Germany
Augustinum Klinik München
München, Bavaria, Germany
Krankenhaus Landshut-Achdorf, LAKUMED Kliniken
Landshut, Germany, Germany
Universitäres Herz- und Gefäßzentrum
Hamburg, Hamburg, Germany
Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
Rotenburg an der Fulda, Hesse, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
Essen, North Rhine-Westphalia, Germany
Krankenhaus Barmherzige Brüder Trier
Trier, Rhineland-Palatinate, Germany
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony, Germany
Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
Bad Oldesloe, Schleswig-Holstein, Germany
Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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Wolfgang Rottbauer, Prof. Dr. med.
Role: primary
References
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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.
Other Identifiers
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GE IDE No. L00123
Identifier Type: -
Identifier Source: org_study_id
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