Access Safety and Efficacy Post Endovascular Intervention (ASPEN)
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|ClinicalTrials.gov Identifier: NCT01773148|
Recruitment Status : Unknown
Verified February 2015 by Arstasis, Inc..
Recruitment status was: Active, not recruiting
First Posted : January 23, 2013
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease.||Device: Arstasis Access System (AXERA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AXERA Access Safety and Efficacy Post Endovascular INtervention|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||June 2015|
Experimental: Arstasis Access System (AXERA) placement
Placement of AXERA device in subjects undergoing common femoral artery access for PCI and/or PVI through a 5F or 6F introducer sheath.
Device: Arstasis Access System (AXERA)
Placement of the AXERA device in the Femoral Artery.
- Major Adverse Events [ Time Frame: Procedure through 30 day follow-up. ]Absence of major access site-related complications.
- Device Success [ Time Frame: Day 1-Day of Procedure. ]
- Successful placement of AXERA followed by procedural sheath
- Achievement of hemostasis in conjunction with manual or mechanical compression
- Time to Hemostasis (TTH) [ Time Frame: Immediately following procedural sheath removal. ]Elapsed time between sheath removal and first observed hemostasis.
- Time to Ambulation (TTA) [ Time Frame: Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated. ]Elapsed time between sheath removal to time when subject stands and walks at least 20 feet without re-bleeding.
- Time to Discharge, eligibility (TTD/e) [ Time Frame: Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site. ]Elapsed time between sheath removal and the time when subject is medically able to be discharged.
- Time to Discharge, actual (TTD/a) [ Time Frame: Evaluated following procedural sheath removal until actual discharge. ]Elapsed time between sheath removal and the actual time when subject is discharged.
- Minor Adverse Events [ Time Frame: Procedure through 30 day follow-up. ]Combined rate of minor vascular access-site related complications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773148
|Principal Investigator:||Mark Dorogy, MD||The Medical Center of Central Georgia|