MedTrace Logo

Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions

NCT04960319 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-08-17

No results posted yet for this study

Summary

Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of Intravascular Lithotripsy (IVL) compared to Rotational Atherectomy (RA) treatment in calcified coronary lesions

Conditions

Interventions

DEVICE

Intravascular Lithotripsy

Coronary Angiography. When the anatomic inclusion criteria are met, traverse the lesion with a guidewire. If traversal fails, assign the subject to the registry. After wire traversal has been documented by cine angiography, angiographic, OCT-defined or balloon expansion criteria are met, subject is enrolled. Blood sample for Troponin (hs TnT) baseline measurement has to be taken. The subjects will be randomized in a 1:1 fashion to treatment with either IVL or RA.

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • Asklepios proresearch

    collaborator INDUSTRY

  • Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

    lead OTHER

Principal Investigators

  • Joachim Schofer, MD, PhD · Medical Care Center Prof. Mathey, Prof. Schofer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-07-31
Completion
2024-06-30
FDA Device
Yes

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 NCT04960319 on ClinicalTrials.gov