Status:
UNKNOWN
Safety and Efficacy Evaluation of Orbital Atherectomy System in de Novo Calcified Lesions
Lead Sponsor:
Centre Recherche Cardio Vasculaire Alpes
Conditions:
Angiography
Coronary Calcification
Eligibility:
All Genders
18+ years
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 coronar...
Detailed 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-expa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with an LVEF \< 25%.
- Patient with hypersensitivity to egg, soy or peanut proteins or to one of the active substances 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05417022
Start Date
June 15 2022
End Date
June 1 2025
Last Update
December 20 2023
Active Locations (17)
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1
GCS-ES Axium-Rambot
Aix-en-Provence, France
2
Centre Hospitalier Antibes - Juan-Les-Pins
Antibes, France, 06 606
3
Hôpital Européen de la Roseraie
Aubervilliers, France, 93300
4
Centre Hospitalier d'Avignon
Avignon, France