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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:
• Subjects ≥ 18 years
• Patients with a clinical indication for coronary angioplasty and presenting a de novo calcified 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
Locations
Other Locations
France
GCS-ES Axium-Rambot
NOT_YET_RECRUITING
Aix-en-provence
Centre Hospitalier Antibes - Juan-Les-Pins
RECRUITING
Antibes
Hôpital Européen de la Roseraie
NOT_YET_RECRUITING
Aubervilliers
Centre Hospitalier d'Avignon
RECRUITING
Avignon
Clinique Rhône Durance
NOT_YET_RECRUITING
Avignon
Centre Hospitalier Universitaire de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Pôle Santé République - ELSAN
RECRUITING
Clermont-ferrand
Groupe Hospitalier Mutualiste de Grenoble
RECRUITING
Grenoble
Centre Hospitalier de Haguenau
RECRUITING
Haguenau
Centre Hospitalier Marne la Vallée
RECRUITING
Jossigny
Hôpital de la Timone
RECRUITING
Marseille
Hôpital Privé du Confluent
RECRUITING
Nantes
Centre Hospitalier Universitaire de Nîmes
RECRUITING
Nîmes
Clinique Saint Hilaire
RECRUITING
Rouen
Institut Arnault Tzanck
NOT_YET_RECRUITING
Saint-laurent-du-var
CHU Strasbourg
NOT_YET_RECRUITING
Strasbourg
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer