Treatment of de novo Bifurcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation
Conditions
Interventions
Treatment with the Tryton Side Branch StentTM plus approved main branch DES
Sponsors
Tryton Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the following criteria: General Inclusion Criteria 1. The patient must be >=18 and = 50% (Medina classification 1.1.1; 0.1.1; 1.0.1 by visual assessment); 9. Target lesion located in a native coronary artery; 10. a)Bifurcation lesion main branch reference vessel diameter must be >=2.5 mm to =2.5mm by visual estimate (>=2.25mm by QCA) and =50% and
Exclusion criteria
Exclusion criteria: Patients will be excluded if ANY of the following conditions apply: General Exclusion Criteria 1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test; 2. Patient has had a known diagnosis of STEMI acute myocardial infarction (AMI) within 72 hours preceding the index procedure or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure; 3. Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB elevation; 4. Patients with non-target lesion PCI within 14 days prior to index procedure with continued CK-MB elevation; Angiographic Exclusion Criteria 15. Left main coronary artery disease (protected and unprotected) 16. Trifurcation lesion; 17. Totally occluded target vessel (TIMI flow 0 or 1); 18. Severely calcified target lesion(s); 19. Highly calcified target lesion(s) requiring rotational atherectomy; 20. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment; 21. Angiographic evidence of thrombus in the target lesion(s); Refer to Protocol 1.10 for full list of Exclusion Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Periprocedural MI after PCI CK-MB elevation with value >3 times the upper range limit within the first 48 hours after PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Safety: 1.All-cause and cardiac mortality at 30 days, and 1 year FU; 2. Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual at 30 days to 1 year (presented in 2 ways, assessed per the modified ARC definition and then by the ARC definition); 3. Major Adverse Cardiac Event (MACE) defined as a composite of all cause death, MI (Q wave or non-Q wave, per modified ARC definition), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA or CABG at hospital discharge, 30 days, and to 1 year; 4. The composite of cardiac death, myocardial infarction (Q wave or non-Q wave, per modified ARC definition) > 30 days post-procedure, stent thrombosis, and target vessel revascularization (main branch or side branch); 5. Rates of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late, at 30 days to 1 year. Effectiveness: 1. Device success, defined as attainment of | — |
Countries
Netherlands
Outcome results
None listed