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

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.

Study Overview

• Status: Unknown
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: FISH SP

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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • Recruiting
      • Florida Research Network, LLC
      • Contact: Bret Wiechmann, MD; Phone Number: 352-333-0939
      • Principal Investigator: Bret Wiechmann, MD
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Recruiting
      • Healient Physician Group
      • Contact: Jessica Jones; Email: JJones01@primehealthcare.com
      • Principal Investigator: David Burkart, MD
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • Recruiting
      • North Memorial
      • Contact: Ann Antolick, BSN; Phone Number: 763-581-6600; Email: Ann.Antolick@northmemorial.com
      • Principal Investigator: Osama Ibrahim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment with FISH device; Vascular closure to be performed with FISH device.	Device: FISH SP; The device will be used to close the femoral artery after angiogram and/or endovascular procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Recording of time to hemostasis. TTH < 10 min will signify success	Within 24 hours
Questionnaire Measuring Time to Hemostasis (TTH)	Documentation of time measured from sheath pull to absence of arterial bleeding in minutes:seconds	Within 24 hours
Questionnaire Measuring Time to Ambulation (TTA)	Documentation of time measured form sheath pull to walking 20 feet in minutes:seconds	Within 24 hours
Questionnaire for Patient Comfort	Subjective measure, measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)	Within 30 days of device
Questionnaire for Physician Confidence	Measured every 10 patients	Within 30 days of device use

Collaborators and Investigators

• Sponsor: Morris Innovative Incorporated
• Collaborators: Deborah Heart and Lung Center
• Investigators: Principal Investigator: Richard Kovach, MD, Physician

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Comfort; Confidence; Usage outcomes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 2K17-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes