Clinical Trials Directory

Trials / Completed

CompletedNCT01978860

A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter

A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter in (CTO) Coronary Lesions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Chanan Schneider · Industry
Sex
All
Age
25 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO penetration rate. Each study subject/patient will have a total of one (1) procedure performed for this study.

Detailed description

To be filled later

Conditions

Interventions

TypeNameDescription
DEVICENovaCross, CTOevaluate the safety and performance of the NovaCross™ micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries.

Timeline

Start date
2013-11-01
Primary completion
2014-11-01
Completion
2014-12-01
First posted
2013-11-08
Last updated
2015-10-07

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01978860. Inclusion in this directory is not an endorsement.