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

Vascular Diseases Clinical Trial

— ELITE  

Official title:

ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03412942
• Other study ID #: 2K17-10
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: Morris Innovative Incorporated
• Contact: Linda Dewey
• Phone: 6098931200
• Email: DeweyL[@]deborah.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.).

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• FISH SP
The device will be used to close the femoral artery after angiogram and/or endovascular procedure.

Locations

Country	Name	City	State
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Healient Physician Group	Leawood	Kansas
United States	North Memorial	Robbinsdale	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Morris Innovative Incorporated	Deborah Heart and Lung Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety Questionnaire for Minor Adverse Events	Documentation of minor adverse event rate related to device use (hematoma)	30 day follow-up after device used.
Secondary	Questionnaire Recording Success Rate	Recording of time to hemostasis. TTH < 10 min will signify success	Within 24 hours
Secondary	Questionnaire Measuring Time to Hemostasis (TTH)	Documentation of time measured from sheath pull to absence of arterial bleeding in minutes:seconds	Within 24 hours
Secondary	Questionnaire Measuring Time to Ambulation (TTA)	Documentation of time measured form sheath pull to walking 20 feet in minutes:seconds	Within 24 hours
Secondary	Questionnaire for Patient Comfort	Subjective measure, measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)	Within 30 days of device
Secondary	Questionnaire for Physician Confidence	Measured every 10 patients	Within 30 days of device use