Clinical trial NCT06369142: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
Official title: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Calcified lesion
Percutaneous Coronary Intervention
Stent
Intravascular Lithotripsy
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Gemeinsamer Bundesaussschuss
name: EvidentIQ Germany GmbH
name: Monitoring Services GmbH
name: Technical University of Munich
First posted: 2024-04-16
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Combined endpoint of major cardiac and cerebrovascular events
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Mortality
timeFrame: 12 months after randomization
measure: Cardiac mortality
timeFrame: 12 months after randomization
measure: Non-fatal myocardial infarction
timeFrame: 12 months after randomization
measure: Non-fatal stroke
timeFrame: 12 months after randomization
measure: Clinically indicated target vessel revascularization
timeFrame: 12 months after randomization
measure: Definite stent thrombosis
timeFrame: 12 months after randomization
measure: Clinically indicated non-target vessel revascularization
timeFrame: 12 months after randomization
measure: Hospitalization due to acute coronary syndrome
timeFrame: 12 months after randomization
measure: Symptoms of coronary heart disease (CHD): physical health status
timeFrame: 12 months after randomization
measure: Symptoms of CHD: mental health status
timeFrame: 12 months after randomization
measure: Bleeding during index hospitalization or ≤30 days (BARC 3-5)
timeFrame: 30 days after randomization
measure: Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure)
timeFrame: 12 months after randomization
measure: Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
state: Baden-Württemberg
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
state: Baden-Württemberg
city: Dachau
country: Germany
facility: Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
state: Bavaria
city: Erding
country: Germany
facility: Klinikum Landkreis Erding
state: Bavaria
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
city: Rotenburg a.d.F.
country: Germany
facility: Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung
state: Hessen
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum
state: Nordrhein-Westfalen
city: Bad Oldesloe
country: Germany
facility: Asklepios Klinik Bad Oldesloe Innere Medizin, Kardiologie und Intensivmedizin
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Klinik für Kardiologie, Angiologie und Intensivmedizin Deutsches Herzzentrum der Charité
Study officials:
affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
name: Adnan Kastrati, MD
role: STUDY_CHAIR
References: