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Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

RecruitingNAAges 18 Years - anyAllDeutsches Herzzentrum Muenchen
NCT06369142 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intravascular lithotripsy (IVL)
  • Standard non-IVL methods
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Where

22 sites
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
Heidelberg, Germany
Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
Mannheim, Germany
Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
Singen, Germany
Cardiologikum Herzklinik Ulm MVZ
Ulm, Germany
Universitätsklinikum Ulm
Ulm, Germany
Universitätsklinikum Augsburg A.ö.R.
Augsburg, Germany
Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
Dachau, Germany
Klinikum Landkreis Erding
Erding, Germany

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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