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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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The learning experience of new medical device technologies is a well-defined event but varies widely by device and user. Several factors influence rate of learning, including the device, the patient population the training technique, clear communication, and the rate of usage. Previous publication have reported on the learning curve of vascular closure technologies including; AngioSeal, Perclose \& StarClose. These reports established the curve to be close to 50 experiences in order to provide predictable results.

Many prior studies have studied the safety and efficacy of vascular closure devices. However, it is substantial to also study device success when in the hands of one specific operator. This study will examine 100 consecutive subjects which the FISH vascular closure device will be used on, and examine outcomes in the following way:

Primary Endpoint:

o Safety: Severe adverse events rate (SAE) (Device related only) (transfusion/vessel occlusion)

Secondary Endpoints:

* Safety: minor adverse event rate (MAE) (Hematoma)
* Success rate (Time to Hemostasis (TTH) \< 10min)
* Time to Hemostasis (TTH) mm:ss - measured from sheath pull to absence of arterial bleeding.
* Time to Ambulation (TTA) hh:mm - measured form sheath pull to walking 20 feet.
* Patient comfort - subjective measure (see scale below) measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)
* Physician Confidence and Comfort (C\&C)(measured every 10 patients)

Conditions

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Vascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment with FISH device

Vascular closure to be performed with FISH device.

Group Type OTHER

FISH SP

Intervention Type DEVICE

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

Interventions

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FISH SP

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.).

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes