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EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)

NCT03412942 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-20

No results posted yet for this study

Summary

A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. Study will be conducted in order to establish the level of comfort and confidence that this device provides for both patients and physician in terms of hemodynamic and usage outcomes.

Conditions

  • Vascular Diseases

Interventions

DEVICE

FISH SP

The device will be used to close the femoral artery after angiogram and/or endovascular procedure.

Sponsors & Collaborators

  • Deborah Heart and Lung Center

    collaborator OTHER

  • Morris Innovative Incorporated

    lead INDUSTRY

Principal Investigators

  • Richard Kovach, MD · Physician

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-12-31
Completion
2019-02-28
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 NCT03412942 on ClinicalTrials.gov