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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26216

Enrollment

500

Registered

2015-10-05

Start date

2015-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Coronary Artery Disease

Interventions

PCI with implantation of at least one BVS (bioresorbable vascular scaffolding ) in a de novo lesion located in a native non-grafted artery.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public ContactIlona Kalter

Dokter Stolteweg 96

i.kalter@diagram-zwolle.nl+31 (38)4262999

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)