Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Standard non-IVL methods; Device: Intravascular lithotripsy (IVL)

• Registration Number: NCT06369142
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-16
• Study Start: 2024-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2027-04-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 666

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lesion preparation using other methods than intravascular lithotripsy	Standard non-IVL methods	e.g. cutting or super high pressure balloons and/or ablative procedures
Lesion preparation using coronary intravascular lithotripsy	Intravascular lithotripsy (IVL)	-

Primary Outcome Measures

Name	Time	Method
Combined endpoint of major cardiac and cerebrovascular events	12 months after randomization	all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel

Secondary Outcome Measures

Name	Time	Method
Non-fatal stroke	12 months after randomization
Cardiac mortality	12 months after randomization
Non-fatal myocardial infarction	12 months after randomization
Clinically indicated target vessel revascularization	12 months after randomization
Definite stent thrombosis	12 months after randomization
Clinically indicated non-target vessel revascularization	12 months after randomization
Symptoms of CHD: mental health status	12 months after randomization
Mortality	12 months after randomization
Hospitalization due to acute coronary syndrome	12 months 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)	12 months after randomization
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)	12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status	12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)	30 days after randomization

Trial Locations

Locations (10)

Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin); 🇩🇪 Singen, Baden-Württemberg, Germany

Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie; 🇩🇪 Dachau, Bavaria, Germany

Klinikum Landkreis Erding; 🇩🇪 Erding, Bavaria, Germany

Deutsches Herzzentrum München; 🇩🇪 Munich, Bavaria, Germany

Klinikum Hersfeld Rotenburg GmbH Herz-Kreislauf-Zentrum Institut für Klinische Forschung; 🇩🇪 Rotenburg a.d.F., Hessen, Germany

Elisabeth Krankenhaus Essen Contilia Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie Kardiovaskuläres Studienzentrum; 🇩🇪 Essen, Nordrhein-Westfalen, 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, Germany