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Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

NCT06369142 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Intravascular lithotripsy (IVL)

Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm

DEVICE

Standard non-IVL methods

Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures

Sponsors & Collaborators

  • Gemeinsamer Bundesaussschuss

    collaborator UNKNOWN

  • EvidentIQ Germany GmbH

    collaborator UNKNOWN

  • Monitoring Services GmbH

    collaborator UNKNOWN

  • Technical University of Munich

    collaborator OTHER

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Adnan Kastrati, MD · Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06369142 on ClinicalTrials.gov