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Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

NCT04428177 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-11

No results posted yet for this study

Summary

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

Conditions

  • Coronary Artery Calcification

Interventions

DEVICE

Intravascular lithotripsy

Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel

DEVICE

Standart therapy

conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Czechia

Study Locations

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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 NCT04428177 on ClinicalTrials.gov