ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 6
- Primary Endpoint
- Safety Questionnaire for Major Adverse Events
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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.).
Arms & Interventions
Treatment with FISH device
Vascular closure to be performed with FISH device.
Intervention: FISH SP (Device)
Outcomes
Primary Outcomes
Safety Questionnaire for Major Adverse Events
Time Frame: 30 day follow-up after device used.
Documentation of severe adverse event related to device use (transfusion/vessel occlusion)
Secondary Outcomes
- Safety Questionnaire for Minor Adverse Events(30 day follow-up after device used.)
- Questionnaire Recording Success Rate(Within 24 hours)
- Questionnaire Measuring Time to Hemostasis (TTH)(Within 24 hours)
- Questionnaire Measuring Time to Ambulation (TTA)(Within 24 hours)
- Questionnaire for Patient Comfort(Within 30 days of device)
- Questionnaire for Physician Confidence(Within 30 days of device use)