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.
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
The device will be used to close the femoral artery after angiogram and/or endovascular procedure.
Florida Research Network, LLC
Gainesville, Florida, United States
RECRUITINGHealient Physician Group
Leawood, Kansas, United States
RECRUITINGNorth Memorial
Robbinsdale, Minnesota, United States
RECRUITINGSafety Questionnaire for Major Adverse Events
Documentation of severe adverse event related to device use (transfusion/vessel occlusion)
Time frame: 30 day follow-up after device used.
Safety Questionnaire for Minor Adverse Events
Documentation of minor adverse event rate related to device use (hematoma)
Time frame: 30 day follow-up after device used.
Questionnaire Recording Success Rate
Recording of time to hemostasis. TTH \< 10 min will signify success
Time frame: Within 24 hours
Questionnaire Measuring Time to Hemostasis (TTH)
Documentation of time measured from sheath pull to absence of arterial bleeding in minutes:seconds
Time frame: Within 24 hours
Questionnaire Measuring Time to Ambulation (TTA)
Documentation of time measured form sheath pull to walking 20 feet in minutes:seconds
Time frame: Within 24 hours
Questionnaire for Patient Comfort
Subjective measure, measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)
Time frame: Within 30 days of device
Questionnaire for Physician Confidence
Measured every 10 patients
Time frame: Within 30 days of device use
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