An observational study in Coronary Artery Disease, sponsored by B. Braun Melsungen AG. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by B. Braun Melsungen AG · Observational
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.
The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress.
Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria".
Coroflex® ISAR NEO is intended to be used for
Exclusion Criteria:
treatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
Target Lesion Revascularization (TLR) rate at 12 months
Time frame: 12 months
Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)
MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
Time frame: 12 months
Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)
Time frame: 12 months
Stent thrombosis rates accumulated up to 12 months
Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
Time frame: 12 months
Rate of bleeding complications accumulated up to 12 months
To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.
Time frame: 12 months
Technical/procedural success rate
Time frame: immediately after procedure
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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B. Braun Melsungen AG