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Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

NCT03717675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-12-03

No results posted yet for this study

Summary

This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.

Conditions

  • Coronary Occlusion

Interventions

DEVICE

NovaCross™ Chronic Total Occlusion micro-catheter

The NovaCross™ micro catheter is a guidewire positioning and support micro catheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment. Investigators will use the NovaCross Micro catheter during a standard of care catheterization of patients diagnosed with coronary total occlusion.

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
2018-10-01
Primary Completion
2019-07-17
Completion
2019-11-01
FDA Device
Yes

Countries

  • Israel
  • Poland
  • United Kingdom

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 NCT03717675 on ClinicalTrials.gov