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

Recruiting

• Conditions: Angiography; Coronary Calcification
• Interventions: Device: Diamondback 360TM orbital atherectomy system

• Registration Number: NCT05417022
• Lead Sponsor: Centre Recherche Cardio Vasculaire Alpes

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.

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-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.

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-14
• Study Start: 2022-06-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diamondback 360TM orbital atherectomy system	Diamondback 360TM orbital atherectomy system	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Safety Endpoint : 12 Month MACE	12 months	See MACE definition in the primary outcome.
Efficacy Endpoint : Revascularization success rate	Until hospital discharge after index procedure, average estimated at 48 hours	Revascularization success was defined as successful stent placement with \< 30% residual stenosis and without severe angiographic complications during intervention and/or MACE during the period of the patient's hospitalization.; Severe angiographic complications were defined as severe dissection (Type C to F) , perforation and persistent slow flow or no flow, Atrioventricular conduction disorder.
Safety endpoint : Comparison of MACE with rotational atherectomy	30 days	The safety of Orbital Atherectomy System will be compared to rotational atherectomy by comparing the MACE rate at 1 month recorded in this study and that recorded in the Euro4C Study.

Trial Locations

Locations (17)

Clinique Rhône Durance; 🇫🇷 Avignon, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier Antibes - Juan-Les-Pins; 🇫🇷 Antibes, France

Hôpital Européen de la Roseraie; 🇫🇷 Aubervilliers, France

Centre Hospitalier d'Avignon; 🇫🇷 Avignon, France

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer; 🇫🇷 Toulon, France

Pôle Santé République - ELSAN; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier de Haguenau; 🇫🇷 Haguenau, France

Centre Hospitalier Marne la Vallée; 🇫🇷 Jossigny, France

Hôpital Privé du Confluent; 🇫🇷 Nantes, France

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

GCS-ES Axium-Rambot; 🇫🇷 Aix-en-Provence, France

Groupe Hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, France

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Institut Arnault Tzanck; 🇫🇷 Saint-Laurent-du-Var, France

CHU Strasbourg; 🇫🇷 Strasbourg, France