A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter

Conditions
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Coronary Artery Disease Obliterative, Chronic Total Occlusion (CTO)

Intervention / Treatment
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* Device: Microcatheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TrueCross microcatheter<br>The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects. | Device: Microcatheter<br>* Support and facilitate the placement of the guidewire in the coronary artery with a CTO.<br>* Other names: TrueCross;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure | 
| Clinical Performance/Effectiveness | Angiographic confirmation of successful placement and successful injection of contrast medium into the vessel lumen, Ability of exchange of the guidewire, Safe withdrawal of the TrueCross Single-use Microcatheter. Procedural efficiency measures (procedure time and injected contrast volume). | during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microcatheter, CTO, coronary artery disease, PCI