Patient Comfort With Vascular Closure

NCT ID: NCT00998023

Last Updated: 2011-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-08-31

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.

Detailed Description

The traditional, standard technique of achieving femoral artery hemostasis following diagnostic and interventional catheterization procedures requires compression methods such as manual pressure or clamps held at the puncture site for 10 to 30 minutes, or even longer depending on sheath size and anticoagulation status. This traditional method can be associated with patient discomfort as well as prolonged bed rest, ambulation and hospital discharge.

Over the past decade, Vascular Closure Devices (VCDs), which include collagen hemostasis devices, percutaneous suture-mediated closure devices and metallic clips, have emerged as a novel means for reducing time to hemostasis and ambulation following catheterization procedures performed utilizing femoral arterial access. Previous studies with commercially available VCDs have shown that the reduction in time to hemostasis and time to ambulation and discharge have also led to increased patient satisfaction over manual compression.

The MynxM5 Vascular Closure Device received FDA approval on April 8, 2009. Like the Mynx 6/7F Vascular Closure Device, which received FDA approval on May 16, 2007, both are designed to achieve femoral artery hemostasis via delivery of an extravascular, water-soluble synthetic sealant which expands upon contact with subcutaneous fluids to seal the arteriotomy. In theory, the lack of pressure needed to clamp, suture, clip or cinch, which is required with intravascular closure devices, may provide an advantage in regards to increased patient comfort during closure device deployment when using the Mynx.

Although VCDs have demonstrated an increase in patient comfort and satisfaction over manual compression, little data exists regarding patient comfort when comparing different closure devices. This study is designed to evaluate patient comfort between the MynxM5 and Angio-Seal Evolution Vascular Closure Devices.

Conditions

Vascular Closure

Keywords

Angiogram; Catheter Angiogram

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mynx VCD

Mynx Vascular Closure Device

Group Type: EXPERIMENTAL

Mynx Vascular Closure Device

Intervention Type: DEVICE

Comparison of two different vascular closure devices.

AngioSeal VCD

AngioSeal Vascular Closure Device

Group Type: ACTIVE_COMPARATOR

AngioSeal Vascular Closure Device

Intervention Type: DEVICE

Comparison of two different vascular closure devices.

Interventions

Mynx Vascular Closure Device

Comparison of two different vascular closure devices.

Intervention Type: DEVICE

AngioSeal Vascular Closure Device

Comparison of two different vascular closure devices.

Intervention Type: DEVICE

Other Intervention Names

Mynx; AngioSeal

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Access Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J Mocco, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

479-2009

Identifier Type: -

Identifier Source: org_study_id