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

December 14, 2023 updated by: Centre Recherche Cardio Vasculaire Alpes

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France
        • Not yet recruiting
        • GCS-ES Axium-Rambot
        • Contact:
      • Antibes, France, 06 606
        • Recruiting
        • Centre Hospitalier Antibes - Juan-Les-Pins
        • Contact:
      • Aubervilliers, France, 93300
        • Not yet recruiting
        • Hôpital Européen de la Roseraie
        • Contact:
      • Avignon, France
        • Not yet recruiting
        • Clinique Rhône Durance
        • Contact:
      • Avignon, France
        • Recruiting
        • Centre Hospitalier d'Avignon
        • Contact:
      • Clermont-Ferrand, France
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand
        • Contact:
      • Clermont-Ferrand, France
        • Recruiting
        • Pôle Santé République - ELSAN
        • Contact:
      • Grenoble, France
      • Haguenau, France, 67500
      • Jossigny, France, 77600
        • Recruiting
        • Centre Hospitalier Marne la Vallée
        • Contact:
      • Marseille, France
        • Recruiting
        • Hopital de La Timone
        • Contact:
      • Nantes, France, 44000
        • Recruiting
        • Hopital Prive du Confluent
        • Contact:
      • Nîmes, France
        • Recruiting
        • Centre Hospitalier Universitaire De Nimes
        • Contact:
      • Rouen, France
      • Saint-Laurent-du-Var, France, 06700
        • Not yet recruiting
        • Institut Arnault Tzanck
        • Contact:
      • Strasbourg, France, 67000
      • Toulon, France, 83100
        • Recruiting
        • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients who undergo an angioplasty requiring Diamondback 360TM orbital atherectomy System and who agree to participate in this study will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diamondback 360TM orbital atherectomy system
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

What is the study measuring?

Primary Outcome Measures

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Recherche Cardio Vasculaire Alpes

Investigators

  • Principal Investigator: Jacques Monségu, Groupe Hospitalier Mutualiste de Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02662-39

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Calcification

Clinical Trials on Diamondback 360TM orbital atherectomy system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe