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Studies

Observational Recruiting

NCT05417022 on ClinicalTrials.gov

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

Official title: French Registry to Evaluate the Safety and Efficacy of the Diamondback 360TM Orbital Atherectomy System in the Preparation of Calcified Coronary Lesions Before Implantation of a Coronary Endoprothesis

  • Sponsor: Centre Recherche Cardio Vasculaire Alpes
  • Enrollment: 300 (Estimated)
  • Study start: 2022-06-15 (Actual)
  • Primary completion: 2024-06-01 (Estimated)
  • Study completion: 2025-06-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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.

Conditions

  • Angiography
  • Coronary Calcification

Intervention / Treatment

  • Device: Diamondback 360TM orbital atherectomy system

Primary Outcome Measures

  • Safety Endpoint : Major Adverse Cardiac Event (MACE) (30 days)
    The Diamondback 360°® Orbital Atherectomy System safety was evaluated by a composite of MACE at 30-days post procedure. MACE is composed of : * Myocardial infarction : Type I and/or Type IV * TVR - defined as revascularization at the target vessel after the completion of the index procedure. * Cardiac death.

Countries

France

Locations and Investigators

  • GCS-ES Axium-Rambot, Aix-en-Provence, France (Not yet recruiting)
    • Marc Silvestri
  • Centre Hospitalier Antibes - Juan-Les-Pins, Antibes, France (Recruiting)
    • Anne Bellemain-Appaix
  • Hôpital Européen de la Roseraie, Aubervilliers, France (Not yet recruiting)
    • Hakim Ben-Amer
  • Centre Hospitalier d'Avignon, Avignon, France (Recruiting)
    • Marine Quillot
  • Clinique Rhône Durance, Avignon, France (Not yet recruiting)
    • Jean-Pascal Peyre
  • Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
  • Pôle Santé République - ELSAN, Clermont-Ferrand, France (Recruiting)
    • Nicolas Durel
  • Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France (Recruiting)
    • Jacques Monségu
    • Angélique Grangier
  • Centre Hospitalier de Haguenau, Haguenau, France (Recruiting)
    • Pierre Leddet
  • Centre Hospitalier Marne la Vallée, Jossigny, France (Recruiting)
    • Simon Elhadad
  • Hôpital de la Timone, Marseille, France (Recruiting)
    • Pierre Deharo
  • Hôpital Privé du Confluent, Nantes, France (Recruiting)
    • Ashok Tirouvanziam
  • Centre Hospitalier Universitaire de Nîmes, Nîmes, France (Recruiting)
    • Luc Cornillet
  • Clinique Saint Hilaire, Rouen, France (Recruiting)
    • Alexandre Canville
  • Institut Arnault Tzanck, Saint-Laurent-du-Var, France (Not yet recruiting)
    • Léo Cuénin
  • CHU Strasbourg, Strasbourg, France (Not yet recruiting)
  • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer, Toulon, France (Recruiting)
    • Gonzalo Quaino

Study Officials

  • Jacques Monségu (Principal Investigator) — Groupe Hospitalier Mutualiste de Grenoble