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Evaluation of a new device for treating calcified coronary 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

Centre Recherche Cardio Vasculaire Alpes · NCT05417022

This study is testing a new device that helps treat hard, calcified blockages in heart arteries to see if it makes stent placement safer and more successful for patients.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Recherche Cardio Vasculaire Alpes (other)
Locations17 sites (Aix-en-Provence and 16 other locations)
Trial IDNCT05417022 on ClinicalTrials.gov

What this trial studies

This observational study is a prospective, single-arm, multi-center registry conducted in France to assess the safety and efficacy of the Diamondback 360 TM Orbital Atherectomy System for preparing de novo calcified coronary lesions prior to stent implantation. The study aims to confirm that this device can reduce complications associated with calcified lesions, which complicate stent placement and increase the risk of major adverse cardiac events. The primary endpoints include 30-day major adverse cardiac events (MACE) for safety and procedural success for efficacy. The device uses a diamond-coated crown to abrade calcified plaque, facilitating optimal stent expansion.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a clinical indication for coronary angioplasty and a de novo calcified lesion.

Not a fit: Patients with severely reduced left ventricular ejection fraction or those with specific angiographic complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve outcomes for patients with calcified coronary lesions undergoing stent placement.

How similar studies have performed: Previous clinical trials, such as ORBIT I and ORBIT II, have shown that the orbital atherectomy system can improve clinical outcomes in similar patient populations.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Aix-en-Provence and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Angiography, Coronary Calcification

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.