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

Chronic Total Occlusion (CTO) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030271
• Other study ID #: CIP-003C
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2023
• Source: Insight Lifetech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion (CTO)
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Microcatheter
Support and facilitate the placement of the guidewire in the coronary artery with a CTO.

Locations

Country	Name	City	State
Georgia	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
Greece	Onassis Heart Surgery Centre	Athens
Greece	Red Cross General Hospital	Athens
Singapore	National Heart Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Insight Lifetech Co., Ltd.

Countries where clinical trial is conducted

Georgia,  Greece,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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