Coronary Occlusion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEcoraFlex Catheter
The coraFlex catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
DEVICEcoraForce Catheter
The coraForce catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
DEVICEcoraCross Catheter
The coraCross catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.
Sponsors
ReFlow Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-Procedure Inclusion Criteria: 1. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. 2. Male or non-pregnant female ≥18 years of age at time of consent. 3. Subjects experiencing clinical symptoms suggestive of ischemic heart disease or has evidence of myocardial ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization. 4. Subject is a candidate for PTCA, stenting, and emergency CABG. * Angiographic Inclusion Criteria: 1. A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting CTO criteria {defined as TIMI grade 0 flow} and estimated to be \> 3 months duration by clinical history and/or comparison with a prior angiogram or electrocardiogram.
Exclusion criteria
* Pre-procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE) | Through hospital discharge or 24 hours post-procedure (whichever comes first) | * 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 |
Countries
United States
Contacts
Primary ContactSara Finton
Backup ContactVicky Joshi
Outcome results
None listed