Chronic Total Occlusion (CTO), Coronary Artery Disease Obliterative
Conditions
Keywords
microcatheter, CTO, coronary artery disease, PCI
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMicrocatheter
Support and facilitate the placement of the guidewire in the coronary artery with a CTO.
Sponsors
Insight Lifetech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Subjects who are \>25 years of age. ii. Subjects who are able/willing to provide a written informed consent prior to participating in the clinical investigation. iii. The subject is male or, if female, is either not of childbearing potential or must use effective contraception during participation in this Clinical Investigation. iv. Subject suffering from coronary artery disease requiring percutaneous coronary angiography and/or intervention. v. Lesions classified as CTOs, meaning, TIMI 0 flow within the occluded segment and angiographic or clinical evidence or high likelihood of an occlusion duration \> 3 months vi. Reference vessel diameter ≥2 mm.
Exclusion criteria
i. Coronary angiography and/or intervention contraindications. ii. Subjects with severe arrhythmia. iii. Subjects with severe systemic infection. iv. Subjects with severe coagulation disorder. v. Subjects with severe heart failure, unstable decompensated heart failure, congestive heart failure, or dyspnea who are unable to lie supine on the examination table for angiography. vi. Subjects with prior coronary artery spams or prior heart valve replacement. vii. Currently participating in an investigational drug or another device clinical investigation that has not completed the primary endpoint or that clinically interferes with the current clinical investigation endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance-technical success | during the procedure | Angiographic confirmation of the TrueCross Single-use Microcatheter's ability to support the guidewire in crossing the CTO in the target vessel true lumen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety-observation of AE | ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure | 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. |
| Clinical Performance/Effectiveness | during the procedure | 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). |
Countries
Georgia, Greece, Singapore
Outcome results
None listed