The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials. Participants will undergo percutaneous coronary intervention (PCI) for a chronic total occlusion and be followed for 30 days post-procedure.
The primary objective of this prospective, multicenter, single arm clinical study is to compare the rate of procedure success of the coraCross, coraForce, and coraFlex catheters in facilitating guidewire placement beyond coronary chronic total occlusions to a pre-defined performance goal based on literature. The study population will consist of those 18 years or older with symptomatic ischemic heart disease, undergoing clinically indicated percutaneous recanalization of an occlusive coronary lesion, and meeting all other eligibility criteria. Measures will be assessed through 30 days post-intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The coraFlex catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
The coraForce catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
The coraCross catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
University of Washington Medical Center
Seattle, Washington, United States
Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE)
* Technical success is defined as angiographic confirmation of chronic total occlusion crossing with guidewire placement, facilitated by one or more of the Cora Catheters, in the target vessel true lumen either distal or proximal to the occlusion, depending on the route of access. * MACE includes cardiac death, myocardial infarction {Q-wave or non-Q-wave, with CK-MB \>3 times upper limit of normal}, and target lesion revascularization
Time frame: Through hospital discharge or 24 hours post-procedure (whichever comes first)
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