Clinical trial NCT05417022: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angiography
Coronary Calcification
Lead sponsor: Centre Recherche Cardio Vasculaire Alpes
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo an angioplasty requiring Diamondback 360TM orbital atherectomy System and who agree to participate in this study will be included.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Endpoint : Major Adverse Cardiac Event (MACE)
timeFrame: 30 days
Secondary outcomes:
measure: Efficacy Endpoint : Revascularization success rate
timeFrame: Until hospital discharge after index procedure, average estimated at 48 hours
measure: Safety Endpoint : 12 Month MACE
timeFrame: 12 months
measure: Safety endpoint : Comparison of MACE with rotational atherectomy
timeFrame: 30 days
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: GCS-ES Axium-Rambot
city: Antibes
country: France
facility: Centre Hospitalier Antibes - Juan-Les-Pins
city: Aubervilliers
country: France
facility: Hôpital Européen de la Roseraie
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: Pôle Santé République - ELSAN
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: Jossigny
country: France
facility: Centre Hospitalier Marne la Vallée
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint-Laurent-du-Var
country: France
facility: Institut Arnault Tzanck
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Study officials:
affiliation: Groupe Hospitalier Mutualiste de Grenoble
name: Jacques Monségu
role: PRINCIPAL_INVESTIGATOR
References:
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