N/A
N=64
Patient Comfort With Vascular Closure
Vascular Closure
Bottom Line
View on ClinicalTrials.gov: NCT00998023 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Mean Score on the Visual Analogue Scale — 0.63; 0.59; 2.94; 5.03 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mynx Vascular Closure Device (Device); AngioSeal Vascular Closure Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Score on the Visual Analogue Scale |
0.63; 0.59; 2.94; 5.03 | — |
| SECONDARY Major Complications |
0; 0 | — |
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.
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
- Intraprocedural Exclusion Criteria: Patient has a baseline ipsilateral groin pain rating of >1 on the 0-10 Visual Analog Scale prior to closure device deployment
Data sourced from ClinicalTrials.gov (NCT00998023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.