Status:
COMPLETED
A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
Lead Sponsor:
Insight Lifetech Co., Ltd.
Conditions:
Coronary Artery Disease Obliterative
Chronic Total Occlusion (CTO)
Eligibility:
All Genders
26+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06030271
Start Date
October 13 2022
End Date
March 30 2023
Last Update
September 8 2023
Active Locations (7)
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1
Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic
Tbilisi, Georgia
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
3
Tbilisi Institute of Medicine
Tbilisi, Georgia
4
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia