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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Angiography, Coronary Calcification

Intervention / Treatment
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* Device: Diamondback 360TM orbital atherectomy system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diamondback 360TM orbital atherectomy system<br> | Device: Diamondback 360TM orbital atherectomy system<br>* Use of the Diamondback 360TM orbital atherectomy system in the preparation of calcified coronary lesions before implantation of a coronary endoprothesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint : Major Adverse Cardiac Event (MACE) | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint : Revascularization success rate | 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. | Until hospital discharge after index procedure, average estimated at 48 hours | 
| Safety Endpoint : 12 Month MACE | See MACE definition in the primary outcome. | 12 months | 
| Safety endpoint : Comparison of MACE with rotational atherectomy | 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. | 30 days |