NCT03842813

Brief Summary

The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients. As routine care, each patient will be followed until 12 months after stent implantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,030

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

22 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

2.8 years

First QC Date

February 11, 2019

Last Update Submit

May 6, 2021

Conditions

DiabetesCoronaropathy

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is Target Lesion Failure (TLF) rate at 1 year

    The TLF is defined as cardiac deaths, heart attack in relation with the target vessel or revascularization of the target lesion. If a patient has at least one of these events, he will be considered as TLF.

    1 year post implantation

Secondary Outcomes (6)

  • Major Adverse Cardiac Events (MACE) at 1 year

    1 year

  • Non cardiac deaths at 1 year

    1 year

  • Stent thrombosis at 1 year

    1 year

  • Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy

    1 year

  • Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy

    1 year

  • +1 more secondary outcomes

Interventions

DES-CRE8DEVICE

Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participation to the study will be proposed to all diabetic patients corresponding to the inclusion and exclusion criteria after implantation of one or more coronary stent CRE8. Patients will be consecutively included to limit selection bias.

You may qualify if:

  • ≥18 years old,
  • patient informed and agreed to participate,
  • patient with one or more lesions treated with one or more coronary stent CRE8,
  • patient with a diabete insulin dependent or non-insulin dependant.

You may not qualify if:

  • pregnant or breast-feading women,
  • patient who refused to participate,
  • patient with another lesion treated during the same intervention with a balloon alone or with another stent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Clinique de l'Europe

Amiens, 80090, France

Location

Centre Hospitalier Avignon

Avignon, 84902, France

Location

Centre Hospitalier Beauvais

Beauvais, 60000, France

Location

Clinique Convert

Bourg-en-Bresse, 01004, France

Location

Centre Hospitalier Brive

Brive-la-Gaillarde, 19100, France

Location

Centre Hospitalier Chartres

Chartres, 280018, France

Location

Hôpital Schweitzer

Colmar, 68003, France

Location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, 91106, France

Location

Hôpital Privé de Bourgogne

Dijon, 21000, France

Location

Hôpital Simone Veil

Eaubonne, 95602, France

Location

Clinique Pasteur

Essey-lès-Nancy, 54270, France

Location

Centre Hospitalier Gonesse

Gonesse, 95500, France

Location

Centre Hospitalier Universitaire Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier Haguenau

Haguenau, 67500, France

Location

Centre Hospitalier Saint-Joseph Saint-Luc

Lyon, 69365, France

Location

Clinique Pont de Chaumes

Montauban, 82000, France

Location

Centre Hospitalier Pau

Pau, 64000, France

Location

Clinique Saint-Hilaire

Rouen, 76000, France

Location

Centre Hospitalier Saint-Quentin

Saint-Quentin, 02321, France

Location

Clinique Saint-Joseph

Trélazé, 49800, France

Location

Centre Hospitalier Valence

Valence, 26000, France

Location

Centre Hospitalier Vannes

Vannes, 56017, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julien Vandenwildenberg

    Alvimedica Medical France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

April 9, 2019

Primary Completion

February 1, 2022

Study Completion

July 1, 2022

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(22)