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

Centre Recherche Cardio Vasculaire Alpes

Status: Enrolling

Conditions: Angiography; Coronary Calcification

Treatments: Device: Diamondback 360TM orbital atherectomy system

Study type: Observational

Funder types: Other

Identifiers

NCT05417022

2021-A02662-39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Diamondback 360TM orbital atherectomy system

Treatment:

Device: Diamondback 360TM orbital atherectomy system