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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-13

Study Completion Date

2023-03-30

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.

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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.

Conditions

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Coronary Artery Disease Obliterative Chronic Total Occlusion (CTO)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TrueCross microcatheter

The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects.

Group Type EXPERIMENTAL

Microcatheter

Intervention Type DEVICE

Support and facilitate the placement of the guidewire in the coronary artery with a CTO.

Interventions

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Microcatheter

Support and facilitate the placement of the guidewire in the coronary artery with a CTO.

Intervention Type DEVICE

Other Intervention Names

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TrueCross

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.

Minimum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No