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Patient Comfort With Vascular Closure

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ClinicalTrials.gov Identifier: NCT00998023
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Sponsor:
Collaborator:
Access Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vascular Closure
Interventions Device: Mynx Vascular Closure Device
Device: AngioSeal Vascular Closure Device
Enrollment 64
Recruitment Details Participants were recruited from the clinical practice of the investigator between November 2009 and July 2010.
Pre-assignment Details Participants who had any groin pain before placement of the closure device were excluded.
Arm/Group Title Mynx VCD AngioSeal VCD
Hide Arm/Group Description Mynx Vascular Closure Device AngioSeal Vascular Closure Device
Period Title: Overall Study
Started 32 32
Completed 32 32
Not Completed 0 0
Arm/Group Title Mynx VCD AngioSeal VCD Total
Hide Arm/Group Description Mynx Vascular Closure Device AngioSeal Vascular Closure Device Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  81.3%
22
  68.8%
48
  75.0%
>=65 years
6
  18.8%
10
  31.3%
16
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Female
22
  68.8%
19
  59.4%
41
  64.1%
Male
10
  31.3%
13
  40.6%
23
  35.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 32 participants 64 participants
32 32 64
1.Primary Outcome
Title Mean Score on the Visual Analogue Scale
Hide Description The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).
Time Frame Immediately before vascular closure and immediately after vascular closure.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Mynx VCD AngioSeal VCD
Hide Arm/Group Description:
Mynx Vascular Closure Device
AngioSeal Vascular Closure Device
Overall Number of Participants Analyzed 32 32
Mean (Standard Error)
Unit of Measure: Scores on a Scale
Before Closure 0.63  (1.01) 0.59  (1.04)
After Closure 2.94  (0.42) 5.03  (0.56)
2.Secondary Outcome
Title Major Complications
Hide Description Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention
Time Frame 1 Day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Mynx VCD AngioSeal VCD
Hide Arm/Group Description:
Mynx Vascular Closure Device
AngioSeal Vascular Closure Device
Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mynx VCD AngioSeal VCD
Hide Arm/Group Description Mynx Vascular Closure Device AngioSeal Vascular Closure Device
All-Cause Mortality
Mynx VCD AngioSeal VCD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mynx VCD AngioSeal VCD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mynx VCD AngioSeal VCD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: J Mocco, M.D.
Organization: University of Florida
Phone: 352-273-9000
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00998023     History of Changes
Other Study ID Numbers: 479-2009
First Submitted: October 19, 2009
First Posted: October 20, 2009
Results First Submitted: September 21, 2011
Results First Posted: December 6, 2011
Last Update Posted: December 6, 2011