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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coroflex® ISAR NEO coronary stent system | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Revascularization (TLR) rate at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Coroflex® ISAR NEO is intended to be used for
Exclusion Criteria:
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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".
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| Name | Affiliation | Role |
|---|---|---|
| Rene Koning, MD | Clinique St. Hilaire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique St. Hilaire | Rouen | 76000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38125031 | Derived | Landolff Q, Quillot M, Picard F, Henry P, Sideris G, Bizeau O, Piot C, Jouve B, Rischner J, Mejri M, Charmasson C, Lasserre R, Pouliquen H, Joseph T, Monsegu J, Karsenty B, Martin Yuste V, Richet N, Lapeyre G, Beverelli F, Beygui F, Koning R. In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease. J Interv Cardiol. 2023 Dec 13;2023:8907315. doi: 10.1155/2023/8907315. eCollection 2023. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 months |
| Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events) | 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. | 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. | 12 months |
| Technical/procedural success rate | immediately after procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |