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The objective of this study is to demonstrate the clinical performance of the Tryton Side Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary Artery(LCX).
The registry study will involve the collection of demographic and clinical data, including in-hospital and follow-up data to determine primary composite endpoint of MACE (Major Adverse Cardiac Events) at 9 months and secondary endpoints. Secondary endpoints are defined as successful deployment of the Tryton stent and main vessel DES within the target lesion, angiographic success <30% residual stenosis in LM and LAD/LCX by visual estimate and TIMI 3 flow post procedure, and freedom of in-hospital MACE.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary stent procedure (CSP) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| MACE: cardiac death, non-index procedure related myocardial infarction, TLR, definite stent thrombosis | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success: successful deployment of Tryton stent and MV DES within target lesion, Angiographic success <30% residual stenosis in LM and LAD/LCX bifurcation by visual est. and TIMI flow 3 post procedure and freedom of in-hospital MACE | 9 months | |
| Clinical endpoints: MACE: total death, cardiac death, non-index procedure related MI, Target lesion revascularization (TLR), Target vessel revascularization (TVR), definite stent thrombosis, Procedure related MI |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CAD due to de novo stenotic lesion in the distal part of the LM at the bifurcation of the Left Anterior Descending Artery (LAD) and the Left Circumflex (LCX)
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| Name | Affiliation | Role |
|---|---|---|
| Stylianos A Pyxaras, MD,FESC | Klinikum-Coburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Cobury GmbH | Coburg | 96450 | Germany |
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| 9 months |