NCT06369142 Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
| NCT ID | NCT06369142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Deutsches Herzzentrum Muenchen |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 666 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 666 participants in total. It began in 2024-07-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Adnan Kastrati, MD
STUDY CHAIR
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Frequently Asked Questions
Who can join the NCT06369142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06369142 currently recruiting?
Yes, NCT06369142 is actively recruiting participants. Contact the research team at cassese@dhm.mhn.de for enrollment information.
Where is the NCT06369142 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Mannheim, Germany, Singen, Germany, Ulm, Germany and 11 additional locations.
Who is sponsoring the NCT06369142 clinical trial?
NCT06369142 is sponsored by Deutsches Herzzentrum Muenchen. The principal investigator is Adnan Kastrati, MD at Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen. The trial plans to enroll 666 participants.