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Trial: NCT00998023 [RDF]

Label NCT00998023
Slug nct00998023
Trialid NCT00998023
Lookup name NCT00998023
Lastchanged date December 5, 2011
Firstreceived results date September 21, 2011
Firstreceived date October 19, 2009
Id info nct id NCT00998023
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 64
Number of arms 2
Is section 801
Is fda regulated No
Brief title Patient Comfort With Vascular Closure
Official title Patient Comfort Study With Vascular Closure: Mynx vs. Angio-Seal Evolution
Study type Interventional
Id info nct alias
Completion date August 2010
Verification date November 2011
Why stopped
Id info org study id 479-2009
Required header url
Study design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Source University of Florida
Primary completion date July 2010
Brief summary
Number of groups
Required header download date processed this data on September 07, 2016
Phase N/A
Start date October 2009
Has expanded access No
Biospec descr
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.
Condition browse None
Intervention browse None
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group bdc18ec350467912feb8ea7cf4305429
Oversight info United States: Institutional Review Board (Oversight_info)
Eligibility 3e7bdffe13d5bf95ad2977af492f62e2
Keywords Angiogram, Catheter Angiogram
Conditions Vascular Closure
Locations 21c5b84c467fedb37502b8e97cdd89ba
Links None
Results references None
Arm groups AngioSeal VCD (Arm Group), Mynx VCD (Arm Group)
Location countries United States
Interventions Mynx Vascular Closure Device (Intervention), AngioSeal Vascular Closure Device (Intervention)
Secondary outcomes 821759dfd887dcd385f96bd4cc4078bb
References None
Primary outcomes ed5fee8b47f1c4bd4a2d4eaf5231a641
Removed countries None
Overall officials 8623ca034cc41c6e6371f5e927c6bd1f