Status:
UNKNOWN
EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)
Lead Sponsor:
Morris Innovative Incorporated
Collaborating Sponsors:
Deborah Heart and Lung Center
Conditions:
Vascular Diseases
Eligibility:
All Genders
Phase:
NA
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 clo...
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 p...
Eligibility Criteria
Inclusion
- All patients on which a FISH device will be used for vascular closure, deemed appropriate by the Principal Investigator.
Exclusion
- 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.).
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03412942
Start Date
February 1 2017
End Date
February 1 2019
Last Update
August 20 2018
Active Locations (3)
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1
Florida Research Network, LLC
Gainesville, Florida, United States, 32605
2
Healient Physician Group
Leawood, Kansas, United States, 66211
3
North Memorial
Robbinsdale, Minnesota, United States, 55422