An interventional study of Microcatheter in Coronary Artery Disease Obliterative and Chronic Total Occlusion (CTO), sponsored by Insight Lifetech Co., Ltd.. Completed at 7 sites in 3 countries. Open to participants aged 26 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Insight Lifetech Co., Ltd. · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Insight Lifetech Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects.
Device: Microcatheter
Support and facilitate the placement of the guidewire in the coronary artery with a CTO.
Also known as: TrueCross
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.
Time frame: during the procedure
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.
Time frame: ADE: during the procedure; non-device/procedure related AE: from screening start to the end of the procedure
Clinical Performance/Effectiveness
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).
Time frame: during the procedure
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Insight Lifetech Co., Ltd.