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ACTIVE NOT RECRUITING
NCT05394649
NA

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

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2022-08-04

Completion Date

2027-12-31

Last Updated

2026-10-30

Healthy Volunteers

No

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.

Locations (17)

Groupe SAnté Victor Pauchet

Amiens, France

Clinique Rhône Durance

Avignon, France

CHU Jean Minjoz

Besançon, France

CHU Bordeaux

Bordeaux, France

Clinique Saint Augustin

Bordeaux, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

GH Mutualiste Grenoble

Grenoble, France

Institut Cardiologique Paris sud

Massy, France

Clinique du Millénaire

Montpellier, France

Clinique Pasteur

Nancy, France

Nouvelle Clinique Nantaise

Nantes, France

CHU Nîmes

Nîmes, France

Hôpital Européen de Paris GVM la Roseraie

Paris, France

Institut Mutualiste Montsouris

Paris, France

CHU Poitiers

Poitiers, France

Clinique Saint Hilaire

Rouen, France

Clinique Pasteur

Toulouse, France