Clinical trial NCT06030271: A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
Official title: A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease Obliterative
Chronic Total Occlusion (CTO)
Keywords: microcatheter, CTO, coronary artery disease, PCI
Lead sponsor: Insight Lifetech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Performance-technical success
timeFrame: during the procedure
Secondary outcomes:
measure: Safety-observation of AE
timeFrame: ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure
measure: Clinical Performance/Effectiveness
timeFrame: during the procedure
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Tbilisi
country: Georgia
facility: Tbilisi Institute of Medicine
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
city: Athens
country: Greece
facility: Onassis Heart Surgery Centre
city: Athens
country: Greece
facility: Red Cross General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
References: