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

NCT05417022 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-12-20

No results posted yet for this study

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.

Conditions

  • Angiography
  • Coronary Calcification

Interventions

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

Sponsors & Collaborators

  • Centre Recherche Cardio Vasculaire Alpes

    lead OTHER

Principal Investigators

  • Jacques Monségu · Groupe Hospitalier Mutualiste de Grenoble

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-06-01
Completion
2025-06-01
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417022 on ClinicalTrials.gov