No registrations found.
ID
Source
Brief title
Health condition
Diabetes Mellitus, Coronary Artery Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the 1-year composite rate of patient oriented major adverse cardiac events (MACE) defined as a composite of:
•Death
•Myocardial infarction (MI)
•Ischemic-driven target vessel revascularization (TVR)
Secondary outcome
To evaluate the 1-year:
•Lesion oriented safety and efficacy composite of Cardiac death, MI, target lesion revascularization (TLR)
•Patient morbidity oriented endpoint of re-hospitalization due to unstable or crescendo angina pectoris.
•Device implantation success
•Procedure success
Background summary
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.
Study objective
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.
Study design
• 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
Intervention
PCI with implantation of at least one BVS (bioresorbable vascular scaffolding ) in a de novo lesion located in a native non-grafted artery.
Ilona Kalter
Zwolle 8025 AZ
The Netherlands
+31 (38)4262999
i.kalter@diagram-zwolle.nl
Ilona Kalter
Zwolle 8025 AZ
The Netherlands
+31 (38)4262999
i.kalter@diagram-zwolle.nl
Inclusion criteria
•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.
Exclusion criteria
•Pregnancy
•Patients unable to provide informed consent
•Known ejection fraction <30%
•Life expectancy < 3 years
•Inability to take dual antiplatelet therapy for 12 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5338 |
| NTR-old | NTR5447 |
| Other | METC : 15.0242 |