Treatment of de novo Bifurcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation
Conditions
Interventions
Prospective, multicenter, randomized, single blind controlled study.
Number of groups : 2
Group 1 :
treatment(s) : treatment with theTryton Side Branch StentTM plus approved main
branch DES
Group
Sponsors
Tryton Medical Corporate Headquarters
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 =2.5 mm to =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 7 days prior to index procedure with continued CK-MB elevation; Angiographic Exclusion Criteria 5. Left main coronary artery disease (protected and unprotected) 6. Trifurcation lesion; 7. Totally occluded target vessel (TIMI flow 0 or 1); 8. Severely calcified target lesion(s); 9. Highly calcified target lesion(s) requiring rotational atherectomy; 10. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment; 11. Angiographic evidence of thrombus in the target lesion(s); Refer to Protocol for full list of Exclusion Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Target Vessel Failure (TVF) defined as the composite of cardiac death, target vessel myocardial infarction (Q wave or non-Q wave) and target vessel revascularization (main branch or side branch) of the Tryton Side Branch Stent* with main branch DES compared to side branch balloon angioplasty and main branch DES at 9 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Powered Secondary Angiographic Endpoint (Angiographic Cohort): In-segment % diameter stenosis of the Tryton Side Branch Stent* compared to side branch balloon angioplasty at 9 months post-procedure. Safety: 1. All-cause and cardiac mortality at 30 days, 6 and 9 months, and annually up to 5 years; 2. Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual at 30 days, 6 and 9 months, and annually up to 5 years; 3. Major Adverse Cardiac Event (MACE) defined as a composite of all cause death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA or CABG at hospital discharge, 30 days, 6 and 9 months, and annually up to 5 years; 4. The composite of cardiac death, myocardial infarction (Q wave or non-Q wave) > 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, 6 and 9 months, and annually up to 5 years. Effectiveness: 6. Device success, defined as attainment of | — |
Countries
Netherlands
Outcome results
None listed