Vascular Diseases
Conditions
Keywords
Comfort, Confidence, Usage outcomes
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)
Interventions
DEVICEFISH SP
The device will be used to close the femoral artery after angiogram and/or endovascular procedure.
Sponsors
Deborah Heart and Lung Center
Morris Innovative Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Questionnaire for Major Adverse Events | 30 day follow-up after device used. | Documentation of severe adverse event related to device use (transfusion/vessel occlusion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Recording Success Rate | Within 24 hours | Recording of time to hemostasis. TTH \< 10 min will signify success |
| Questionnaire Measuring Time to Hemostasis (TTH) | Within 24 hours | Documentation of time measured from sheath pull to absence of arterial bleeding in minutes:seconds |
| Safety Questionnaire for Minor Adverse Events | 30 day follow-up after device used. | Documentation of minor adverse event rate related to device use (hematoma) |
| Questionnaire for Patient Comfort | Within 30 days of device | Subjective measure, measured baseline (pre-procedure/ post procedure/ 15 days and 30 days) |
| Questionnaire for Physician Confidence | Within 30 days of device use | Measured every 10 patients |
| Questionnaire Measuring Time to Ambulation (TTA) | Within 24 hours | Documentation of time measured form sheath pull to walking 20 feet in minutes:seconds |
Countries
United States
Contacts
Primary ContactLinda Dewey
Outcome results
None listed