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

Not Applicable

Completed

• Conditions: Coronary Artery Disease Obliterative; Chronic Total Occlusion (CTO)
• Interventions: Device: Microcatheter

• Registration Number: NCT06030271
• Lead Sponsor: Insight Lifetech Co., Ltd.

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.

Study Timeline

• Study Start: 2022-10-13
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

Red Cross General Hospital; 🇬🇷 Athens, Greece

Onassis Heart Surgery Centre; 🇬🇷 Athens, Greece

Tbilisi Institute of Medicine; 🇬🇪 Tbilisi, Georgia

Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic; 🇬🇪 Tbilisi, Georgia

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore