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Everolimus-eluting Bioresorbable Scaffolds for Treatment of Coronary Artery Disease in Patients with Diabetes Mellitus. International, Multicenter, Observational, Prospective Registry Study


- candidate number22944
- NTR NumberNTR5447
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-okt-2015
- Secondary IDs15.0242 METC
- Public TitleEverolimus-eluting Bioresorbable Scaffolds for Treatment of Coronary Artery Disease in Patients with Diabetes Mellitus. International, Multicenter, Observational, Prospective Registry Study
- Scientific TitleEverolimus-eluting Bioresorbable Scaffolds for Treatment of Coronary Artery Disease in Patients with Diabetes Mellitus. International, Multicenter, Observational, Prospective Registry Study
- ACRONYMABSORB DM registry
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Coronary artery disease
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2015
- planned closingdate1-dec-2017
- Target number of participants500
- InterventionsPCI with implantation of at least one BVS (bioresorbable vascular scaffolding ) in a de novo lesion located in a native non-grafted artery.
- Primary outcomeTo 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 outcomeTo 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
- Timepoints• 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
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Ilona Kalter
- CONTACT for SCIENTIFIC QUERIES E. Kedhi
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Clinics, Department of Cardiology
- Publications
- Brief summaryInternational, 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.
- Main changes (audit trail)
- RECORD5-okt-2015 - 22-nov-2015


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