A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Insight Lifetech Co., Ltd.
- Enrollment
- 60
- Locations
- 7
- Primary Endpoint
- Clinical Performance-technical success
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 26 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Clinical Performance-technical success
Time Frame: 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 Outcomes
- Safety-observation of AE(ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure)
- Clinical Performance/Effectiveness(during the procedure)