NCT05417022

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Centre Recherche Cardio Vasculaire Alpes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Angiography
• Coronary Calcification

Interventions

Type	Name	Description
DEVICE	Diamondback 360TM orbital atherectomy system	Use of the Diamondback 360TM orbital atherectomy system in the preparation of calcified coronary lesions before implantation of a coronary endoprothesis

Timeline

• Start date: 2022-06-15
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2022-06-14
• Last updated: 2023-12-20

Locations

17 sites across 1 country: France

Regulatory

• FDA-regulated device study