Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
St. Luke's Medical Center
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Technical Success
Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire
Time frame: Intraprocedural
30-day Major Adverse Cardiac Event (MACE) Rate
Defined as cardiac death, Q-wave and non-Q-wave \[total creatinine kinase (CK) \>2x upper limit of normal with a positive myocardial band (MB) fraction\] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.
Time frame: 30 Days
Total Procedure Time
Minus any time to determine CTO was refractory to standard guidewire
Time frame: Intraprocedural
Total Procedural Fluoroscopy Time
Minus any time to determine CTO was refractory to standard guidewire
Time frame: Intraprocedural
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