EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)
ELITE
ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device
1 other identifier
interventional
100
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 20, 2018
August 1, 2018
1.8 years
October 11, 2017
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Questionnaire for Major Adverse Events
Documentation of severe adverse event related to device use (transfusion/vessel occlusion)
30 day follow-up after device used.
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
Treatment with FISH device
OTHERVascular closure to be performed with FISH device.
Interventions
The device will be used to close the femoral artery after angiogram and/or endovascular procedure.
Eligibility Criteria
You may qualify if:
- All patients on which a FISH device will be used for vascular closure, deemed appropriate by the Principal Investigator.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morris Innovative Incorporatedlead
- Deborah Heart and Lung Centercollaborator
Study Sites (3)
Florida Research Network, LLC
Gainesville, Florida, 32605, United States
Healient Physician Group
Leawood, Kansas, 66211, United States
North Memorial
Robbinsdale, Minnesota, 55422, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Kovach, MD
Physician
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2017
First Posted
January 29, 2018
Study Start
February 1, 2017
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
August 20, 2018
Record last verified: 2018-08