Patient Comfort With Vascular Closure

NCT00998023 | Completed Results

• 1 other identifier: 479-2009
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to collect information on the amount of discomfort patients experience with one of two different vascular blood vessel closure devices, the MynxM5 Vascular Closure Device and the Angio-Seal Evolution Vascular Closure Device.

Conditions

Vascular Closure

Keywords

Angiogram; Catheter Angiogram

Outcome Measures

Primary Outcomes (1)

• Mean Score on the Visual Analogue Scale

  The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).

  Immediately before vascular closure and immediately after vascular closure.

Secondary Outcomes (1)

• Major Complications

  1 Day

Study Arms (2)

Mynx VCD

EXPERIMENTAL

Mynx Vascular Closure Device

Device: Mynx Vascular Closure Device

AngioSeal VCD

ACTIVE COMPARATOR

AngioSeal Vascular Closure Device

Device: AngioSeal Vascular Closure Device

Interventions

Mynx Vascular Closure Device DEVICE

Comparison of two different vascular closure devices.

Also known as: Mynx

Mynx VCD

AngioSeal Vascular Closure Device DEVICE

Comparison of two different vascular closure devices.

Also known as: AngioSeal

AngioSeal VCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \>18 years of age
• Patient has been informed and understands the nature of the study and provides written Informed Consent approved by the appropriate Institutional Review Board prior to enrollment
• Patient has been trained and understands the use of the 0-10 Visual Analogue Scale as an assessment of patient pain
• Patient is scheduled to undergo a diagnostic endovascular procedure involving percutaneous access through the common femoral artery

You may not qualify if:

• Per Mynx and Angio-Seal Instructions for Use
• Patient has a documented psychiatric disorder (e.g. major depression, anxiety)
• Patient has a documented chronic pain condition requiring daily treatment
• Patient carries the diagnoses of a known bleeding disorder

Sponsors & Collaborators

• University of Florida: lead
• Access Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Limitations and Caveats

The Angio-Seal Evolution is only one of a variety of potential vascular closure devices available on the market that would be suitable for comparison with the Mynx; however, this study was limited to just one of such alternative devices.

Results Point of Contact

• Title: J Mocco, M.D.
• Organization: University of Florida

jmocco@neurosurgery.ufl.edu

352-273-9000

Study Officials

• J Mocco, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 6, 2011
• Results First Posted: December 6, 2011

Record last verified: 2011-11

Locations

US (1)