The ABSORB DM registry is designed to perform follow-up of all DM patients who have undergone ABSORB family placement. This international database will allow follow-up of all adverse events related to the product and/or the procedure.…
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus, Coronary Artery Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the 1-year composite rate of patient oriented major adverse cardiac events (MACE) defined as a composite of:<br>
•Death<br>
•Myocardial infarction (MI)<br>
•Ischemic-driven target vessel revascularization (TVR)
Achtergrond van het onderzoek
International, multicenter, observational, prospective registry study to evaluate the performance of everolimus-eluting bioabsorbable scaffolds (EE-BRS) in patients with diabetes mellitus (DM).
500 patients will be enrolled in Belgium, Luxembourg and Netherlands. DM patient data providing from the France ABSORB register (a simultaneous parallel running 2000 all-comer patients register) will be pooled. Therefore the total population of ABSORB Diabetes is expected to be approximately 750 patients.
Patients will be included over 1 year, with a 1-year follow-up period.
Primary endpoint: A patient oriented composite endpoint of Death, MI, and target vessel revascularization (TVR) at 1 year.
Doel van het onderzoek
The ABSORB DM registry is designed to perform follow-up of all DM patients who have undergone ABSORB family placement. This international database will allow follow-up of all adverse events related to the product and/or the procedure.
Specifically, it will allow: Post-CE marking surveillance, with safety and clinical follow-up outcomes in the context of the use of the product in DM patients in a real-life clinical practice.
Onderzoeksopzet
• First patient included: Q2 2015
• Last patient included: Q4 2016
• Completed 1 year FU: Q4 2017
Note: longer follow-up (3 and 5 years Fup) will be performed if funding allows
Onderzoeksproduct en/of interventie
PCI with implantation of at least one BVS (bioresorbable vascular scaffolding ) in a de novo lesion located in a native non-grafted artery.
Algemeen / deelnemers
Ilona Kalter
Zwolle 8025 AZ
The Netherlands
+31 (38)4262999
i.kalter@diagram-zwolle.nl
Wetenschappers
Ilona Kalter
Zwolle 8025 AZ
The Netherlands
+31 (38)4262999
i.kalter@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
•Patients aged 18 years or older.
•History of DM
•PCI with implantation of at least one BVS in a de novo lesion located in a native non-grafted artery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•Pregnancy
•Patients unable to provide informed consent
•Known ejection fraction <30%
•Life expectancy < 3 years
•Inability to take dual antiplatelet therapy for 12 months
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5338 |
| NTR-old | NTR5447 |
| Ander register | METC : 15.0242 |