TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent
The primary objective of this PAS is to assure the continued safety and effectiveness of the Tryton Side Branch Stent™ with main branch approved DES in the treatment of de novo native coronary artery bifurcation lesions with side branch diameter ranging from ≥2.5 mm to ≤3.5 mm and main branch diameter ranging from ≥2.5 mm to ≤4.0 mm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
335
Interventional coronary artery stent placement in De novo bifurcation lesions of the MB \& SB
NC Heart and Vascular Research/UNC REX
Raleigh, North Carolina, United States
RECRUITINGTarget Vessel Failure (TVF)
Composite of cardiac death, target vessel MI (Q and non-Qwave) clinically driven target vessel revascularization
Time frame: 1 year
Device success
Attainment of \<30% residual stenosis within the side branch without device malfunction
Time frame: 48 hrs
Lesion success
Attainment of \<30% residual stenosis using any percutaneous method
Time frame: 48 hrs
Procedure success
Lesion success without the occurrence of in-hospital MACE
Time frame: 48 hrs
Death
All-cause and cardiac mortality
Time frame: 1 year
Myocardial infarction (MI)
Q wave and Non-Q wave
Time frame: 1 year
CD-TLR
Clinically driven target lesion revascularization
Time frame: 1 year
CD-TVR
Clinically driven target vessel revascularization
Time frame: 1 year
Stent thrombosis
ARC definition of definite and probable
Time frame: 1 year
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