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Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

NCT05394649 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2022-08-10

No results posted yet for this study

Summary

The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

Conditions

  • Intravascular Lithotripsy; Rotational Atherectomy; OFDI

Interventions

DEVICE

Intravascular Lithotripsy

A new device has been designed by Shockwave Medical Inc. for the treatment of calcified vascular lesions to support stent delivery: the "C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system". The system is based on lithotripsy to induce microfractures in the calcified plaque before low-pressure balloon dilation. The C2 Shockwave Medical® coronary lithotripsy (IVL) system consists of an IVL Catheter with two lithotripsy emitters enclosed within an integrated balloon, an IVL Generator, and an IVL Connector Cable.

DEVICE

Rotational Atherectomy

Rotational Atherectomy is a technique of calcic coronary plaque preparation based on the debulking of superficial calcium by a high-speed burr in order to improve vessel compliance and immediate vessel lumen gain before stenting.

Sponsors & Collaborators

  • Clinique Pasteur Toulouse

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2024-05-31
Completion
2025-05-31

Countries

  • France

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 NCT05394649 on ClinicalTrials.gov