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

NCT01978860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-10-07

No results posted yet for this study

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.

Conditions

  • Chronic Total Occlusion of Coronary Artery

Interventions

DEVICE

NovaCross, CTO

evaluate 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.

Sponsors & Collaborators

  • Clinical Research Consultants, Inc.

    collaborator INDUSTRY

  • Chanan Schneider

    lead INDUSTRY

Principal Investigators

  • Chaim - Lotan, MD · Hadassah Ein Karem, Jerusalem Israel

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
2013-11-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • Israel

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 NCT01978860 on ClinicalTrials.gov