The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter.
The objective of this clinical investigation is to evaluate the performance and safety of the TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the related clinical benefits. The study will include 59 subjects suffering from coronary artery disease requiring a percutaneous coronary intervention. Enrollment duration will be 4 months or so without follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious protocol deviation or procedure interruption unrelated to the catheter), subjects will be replaced to reach 59 evaluable subjects for the Per Protocol population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Support and facilitate the placement of the guidewire in the coronary artery with a CTO.
Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Tbilisi Institute of Medicine
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia
Clinical Performance-technical success
Angiographic confirmation of the TrueCross Single-use Microcatheter's ability to support the guidewire in crossing the CTO in the target vessel true lumen.
Time frame: during the procedure
Safety-observation of AE
Occurrence of any device related adverse event during use of the microcatheter throughout the procedure. Occurrence of any non-device/procedure related events from screening start to the end of the procedure. This will include any events related or cause by other devices used independently from the TrueCross Single-use Microcatheter during the same PCI procedure.
Time frame: ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure
Clinical Performance/Effectiveness
1. Angiographic confirmation of successful placement and successful injection of contrast medium into the vessel lumen, 2. Ability of exchange of the guidewire, 3. Safe withdrawal of the TrueCross Single-use Microcatheter. 4. Procedural efficiency measures (procedure time and injected contrast volume).
Time frame: during the procedure
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Onassis Heart Surgery Centre
Athens, Greece
Red Cross General Hospital
Athens, Greece
National Heart Centre Singapore
Singapore, Singapore