NCT06030271

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 1, 2023

Last Update Submit

September 1, 2023

Conditions

Coronary Artery Disease ObliterativeChronic Total Occlusion (CTO)

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

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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Israeli-Georgian Medical Research Clinic Ltd - Healthycore Clinic

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

Tbilisi Institute of Medicine

Tbilisi, Georgia

Location

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

Location

Onassis Heart Surgery Centre

Athens, Greece

Location

Red Cross General Hospital

Athens, Greece

Location

National Heart Centre Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

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

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

SG(1)GE(4)GR(2)