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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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)

Official Title
-----------------
ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Device: FISH SP


Participation Criteria
=================
Eligibility Criteria
-----------------
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.).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment with FISH device<br>Vascular closure to be performed with FISH device. | Device: FISH SP<br>* The device will be used to close the femoral artery after angiogram and/or endovascular procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Questionnaire for Major Adverse Events | Documentation of severe adverse event related to device use (transfusion/vessel occlusion) | 30 day follow-up after device used. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Questionnaire for Minor Adverse Events | Documentation of minor adverse event rate related to device use (hematoma) | 30 day follow-up after device used. | 
| Questionnaire Recording Success Rate | Recording of time to hemostasis. TTH < 10 min will signify success | Within 24 hours | 
| Questionnaire Measuring Time to Hemostasis (TTH) | Documentation of time measured from sheath pull to absence of arterial bleeding in minutes:seconds | Within 24 hours | 
| Questionnaire Measuring Time to Ambulation (TTA) | Documentation of time measured form sheath pull to walking 20 feet in minutes:seconds | Within 24 hours | 
| Questionnaire for Patient Comfort | Subjective measure, measured baseline (pre-procedure/ post procedure/ 15 days and 30 days) | Within 30 days of device | 
| Questionnaire for Physician Confidence | Measured every 10 patients | Within 30 days of device use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comfort, Confidence, Usage outcomes