Safety and Efficacy Evaluation of Orbital Atherectomy System in de Novo Calcified Lesions

Last updated: December 14, 2023
Sponsor: Centre Recherche Cardio Vasculaire Alpes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scleroderma

Treatment

Diamondback 360TM orbital atherectomy system

Clinical Study ID

NCT05417022
2021-A02662-39
  • Ages > 18
  • All Genders

Study Summary

This is a French, prospective, single-arm, multi-center registry to confirm the safety and efficacy of the Diamondback 360 TM Orbital Atherectomy System in the preparation of de novo calcified coronary lesions before implantation of a coronary endoprothesis in adult subjects. The primary safety endpoint is 30-day MACE and the efficacy endpoint is procedural success.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects ≥ 18 years
  • Patients with a clinical indication for coronary angioplasty and presenting a de novocalcified lesion
  • The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
  • Lesion length <= 40 mm
  • The target vessel must be a coronary artery with a stenosis of >70%
  • Patients able to understand and provide informed consent
  • Patients with Social Security coverage

Exclusion

Exclusion Criteria:

  • Patients with an LVEF < 25%.
  • Patient with hypersensitivity to egg, soy or peanut proteins or to one of the activesubstances or one of the excipients of ViperSlide lubricant.
  • Pregnant or breastfeeding woman
  • Unwilling or unable to sign the Informed Consent
  • Patients under judicial protection, tutorship or curatorship
  • Angiographic criteria: Intra-stent stenosis, Presence of a chronic total occlusion (CTO), Bypass lesion, Target vessel excessively tortuous, Presence of a thrombus,Presence of a single permeable vessel

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Diamondback 360TM orbital atherectomy system
Phase:
Study Start date:
June 15, 2022
Estimated Completion Date:
June 01, 2025

Study Description

Treatment of calcified lesions, caused in 6 to 20% of patients, remains a challenge.

Presence of coronary calcifications complicates stent placement resulting in up to 50% malapposition or under-expansion of the stent and is associated with a higher frequency of major adverse cardiac events (MACE).

In order to reduce these risks, preparation of these lesions before the implantation of a coronary stent is essential. The arrival on the European market of a new Orbital atherectomy system leads to consider its use in the preparation of such lesions.

The orbital atherectomy system uses a diamond-coated eccentric crown that abrades calcified plaque and develops pulsatile forces on the wall. It reduces calcified plaque and modifies plaque with fractures, facilitating stent placement and allowing for optimal stent expansion.

ORBIT I and ORBIT II clinical trials were conducted in the United States to evaluate the safety of using the Orbital Atherectomy System in de novo calcified coronary lesions in adults. These 2 trials demonstrated that orbital atherectomy not only facilitated stenting, but also improved clinical outcomes compared to historical outcomes.

The recent obtaining of CE marking allows the use of this very promising medical device in France.

Connect with a study center

  • GCS-ES Axium-Rambot

    Aix-en-Provence,
    France

    Site Not Available

  • Centre Hospitalier Antibes - Juan-Les-Pins

    Antibes, 06 606
    France

    Active - Recruiting

  • Hôpital Européen de la Roseraie

    Aubervilliers, 93300
    France

    Site Not Available

  • Centre Hospitalier d'Avignon

    Avignon,
    France

    Active - Recruiting

  • Clinique Rhône Durance

    Avignon,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Pôle Santé République - ELSAN

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble,
    France

    Active - Recruiting

  • Centre Hospitalier de Haguenau

    Haguenau, 67500
    France

    Active - Recruiting

  • Centre Hospitalier Marne la Vallée

    Jossigny, 77600
    France

    Active - Recruiting

  • Hôpital de la Timone

    Marseille,
    France

    Active - Recruiting

  • Hôpital Privé du Confluent

    Nantes, 44000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes,
    France

    Active - Recruiting

  • Clinique Saint Hilaire

    Rouen,
    France

    Active - Recruiting

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var, 06700
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg, 67000
    France

    Site Not Available

  • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

    Toulon, 83100
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.