Clinical trial NCT03412942: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)
Official title: ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Diseases
Keywords: Comfort
Confidence
Usage outcomes
Lead sponsor: Morris Innovative Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Deborah Heart and Lung Center
First posted: 2018-01-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

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.).

Primary outcomes:
measure: Safety Questionnaire for Major Adverse Events
timeFrame: 30 day follow-up after device used.
Secondary outcomes:
measure: Safety Questionnaire for Minor Adverse Events
timeFrame: 30 day follow-up after device used.
measure: Questionnaire Recording Success Rate
timeFrame: Within 24 hours
measure: Questionnaire Measuring Time to Hemostasis (TTH)
timeFrame: Within 24 hours
measure: Questionnaire Measuring Time to Ambulation (TTA)
timeFrame: Within 24 hours
measure: Questionnaire for Patient Comfort
timeFrame: Within 30 days of device
measure: Questionnaire for Physician Confidence
timeFrame: Within 30 days of device use
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Leawood
country: United States
facility: Healient Physician Group
state: Kansas
city: Robbinsdale
country: United States
facility: North Memorial
state: Minnesota
Study officials:
affiliation: Physician
name: Richard Kovach, MD
role: PRINCIPAL_INVESTIGATOR
References: