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Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

NCT03719014 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-11-06

No results posted yet for this study

Summary

A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

Conditions

  • Coronary Occlusion

Interventions

DEVICE

NovaCross

The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.

Sponsors & Collaborators

  • Nitiloop Ltd.

    lead INDUSTRY

Principal Investigators

  • Simon Walsh, MD · Belfast Health and Social Care Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-04-30
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719014 on ClinicalTrials.gov