EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Pat... | NCT03412942

Studies
EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)

NCT03412942

Sponsor

Morris Innovative Incorporated

Status

Unknown status

Last Update Posted

Aug 20, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Vascular Diseases

Interventions

FISH SP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Feb 2019Estimated

First Submitted Date

Oct 11, 2017

First Submission Date that Met QC Criteria

Jan 25, 2018

First Posted Date

Jan 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 20, 2018Actual

Name	Class
Deborah Heart and Lung Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with FISH device	Other	Vascular closure to be performed with FISH device.	Device: FISH SP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FISH SP	Device	The device will be used to close the femoral artery after angiogram and/or endovascular procedure.	Treatment with FISH device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Safety Questionnaire for Minor Adverse Events	Documentation of minor adverse event rate related to device use (hematoma)	30 day follow-up after device used.
Questionnaire Recording Success Rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Linda Dewey	Contact	6098931200	5023	DeweyL@deborah.org

Overall Officials

Name	Affiliation	Role
Richard Kovach, MD	Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Research Network, LLC	Recruiting	Gainesville	Florida	32605	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided