DiabetesEVALU8NCT03842813
Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients
An observational study of Diabetes and Coronaropathy, run by Alvimedica Medical Technologies France at 22 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Coronaropathy
- What is being tested?
- DES-CRE8
- Type of treatment
- Medical device
- How many people
- 1,030 participants
- Where
- 22 sitesFrance
- Study dates
- 9 Apr 2019to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Clinique de l'Europe
Amiens, 80090
Centre Hospitalier Avignon
Avignon, 84902
Centre Hospitalier Beauvais
Beauvais, 60000
Clinique Convert
Bourg-en-Bresse, 01004
Centre Hospitalier Brive
Brive-la-Gaillarde, 19100
Centre Hospitalier Chartres
Chartres, 280018
Hôpital Schweitzer
Colmar, 68003
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, 91106
Hôpital Privé de Bourgogne
Dijon, 21000
Hôpital Simone Veil
Eaubonne, 95602
Clinique Pasteur
Essey-lès-Nancy, 54270
Centre Hospitalier Gonesse
Gonesse, 95500
Centre Hospitalier Universitaire Grenoble
Grenoble, 38043
Centre Hospitalier Haguenau
Haguenau, 67500
Centre Hospitalier Saint-Joseph Saint-Luc
Lyon, 69365
Clinique Pont de Chaumes
Montauban, 82000
Centre Hospitalier Pau
Pau, 64000
Clinique Saint-Hilaire
Rouen, 76000
Centre Hospitalier Saint-Quentin
Saint-Quentin, 02321
Clinique Saint-Joseph
Trélazé, 49800
Centre Hospitalier Valence
Valence, 26000
Centre Hospitalier Vannes
Vannes, 56017
About this study
Official title: Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study
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.
- Conditions
- Diabetes, Coronaropathy
- Being tested
- DES-CRE8
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post implantation
Secondary outcomes (6)
Major Adverse Cardiac Events (MACE) at 1 year
MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.
Measured: 1 year
Non cardiac deaths at 1 year
Non cardiac deaths at 1 year
Measured: 1 year
Stent thrombosis at 1 year
Certain or probable stent thrombosis
Measured: 1 year
Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy
MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.
Measured: 1 year
Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy
Non cardiac deaths at 1 year
Measured: 1 year
Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy
Certain or probable stent thrombosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start9 Apr 2019
- Primary completionFeb 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvimedica Medical Technologies France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Julien Vandenwildenberg, Study chair, Alvimedica Medical France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842813
- Sponsor's protocol ID
- 2018-A02663-52
- Acronym
- EVALU8
- Status last verified
- May 2021
- First submitted
- 11 Feb 2019
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study
- ClinicalTrials.gov ID
- NCT03842813
- Acronym / sponsor ID
- EVALU8 / 2018-A02663-52
- Conditions
- Diabetes, Coronaropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Alvimedica Medical Technologies FranceIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DES-CRE8Polymer-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. | Device | – |
Primary outcome
The primary endpoint is Target Lesion Failure (TLF) rate at 1 year
Time frame: 1 year post implantation
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.
6 secondary outcomes
Major Adverse Cardiac Events (MACE) at 1 year
Time frame: 1 year
Non cardiac deaths at 1 year
Time frame: 1 year
Stent thrombosis at 1 year
Time frame: 1 year
Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy
Time frame: 1 year
Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy
Time frame: 1 year
Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Vandenwildenberg study chair
Alvimedica Medical France
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Coronaropathy, run by Alvimedica Medical Technologies France at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is Target Lesion Failure (TLF) rate at 1 year (time frame: 1 year post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.