Recruiting

Observational Study

Sponsor:

Morris Innovative Incorporated

Code:

NCT03412942

Conditions

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

FISH SP

Study Details

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.

Conditions

Vascular Diseases

Study ID

NCT03412942

Start date

Feb 1, 2017

Status verified date

Aug, 2018

Completion date

Feb, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Treatment with FISH device

Vascular closure to be performed with FISH device.

Interventions

FISH SP

The device will be used to close the femoral artery after angiogram and/or endovascular procedure.

Primary outcome measure

  • Safety Questionnaire for Major Adverse Events [ Time Frame: 30 day follow-up after device used. ]

Central Contacts and Locations

Central contacts

Linda Dewey

6098931200DeweyL@deborah.org

Locations

Florida Research Network, LLC

Recruiting

Gainesville, Florida, United States, 32605

Contacts

Bret Wiechmann, MD

352-333-0939

Principal Investigator:

Bret Wiechmann, MD

Healient Physician Group

Recruiting

Leawood, Kansas, United States, 66211

Contacts

Jessica Jones

JJones01@primehealthcare.com

Principal Investigator:

David Burkart, MD

North Memorial

Recruiting

Robbinsdale, Minnesota, United States, 55422

Contacts

Ann Antolick, BSN

763-581-6600Ann.Antolick@northmemorial.com

Principal Investigator:

Osama Ibrahim, MD

More Information

Sponsor

Morris Innovative Incorporated

Last update posted

Aug 20, 2018

Last verified

Aug, 2018

Keywords

  • Comfort
  • Confidence
  • Usage outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Morris Innovative Incorporated on 2018-08-20.