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

Status unconfirmed · Not applicable

Conditions studied: Vascular Diseases

In brief

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.

Key facts

Study ID

NCT03412942

Run by

Morris Innovative Incorporated

People needed

100

Starts

2017-02-01

Expected to finish

2019-02-01

Last updated by the study team

2018-08-20

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients on which a FISH device will be used for vascular closure, deemed appropriate by the Principal Investigator.

You may not qualify if…

• Patients on which a FISH device will not be used for vascular closure and another method will be used - deemed appropriate by the Principal Investigator (i.e. manual compressions, PerClose, AngioSeal, etc.).

Where it is running

• Florida Research Network, LLC — Gainesville, Florida, United States (enrolling)
• Healient Physician Group — Leawood, Kansas, United States (enrolling)
• North Memorial — Robbinsdale, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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