Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Total Occlusion (CTO)Coronary Artery Disease Obliterative

Keywords

microcatheter, CTO, coronary artery disease, PCI

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

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

Study Arms (1)

TrueCross microcatheter

EXPERIMENTAL

The TrueCross Single-use Microcatheter will be used in percutaneous coronary intervention(PCI) of the enrolled subjects.

Device: Microcatheter

Interventions

MicrocatheterDevice

Support and facilitate the placement of the guidewire in the coronary artery with a CTO.

Also known as: TrueCross

TrueCross microcatheter

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age26 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Insight Lifetech Co., Ltd.
Industrylead

Study Sites (7)

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, Georgia

Onassis Heart Surgery Centre

Athens, Greece

Red Cross General Hospital

Athens, Greece

National Heart Centre Singapore

Singapore, Singapore

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 8, 2023

Study Start

October 13, 2022

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

TrueCross microcatheter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

TrueCross microcatheter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations