Access Safety and Efficacy Post Endovascular Intervention (ASPEN)
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773148
|United States, Alabama|
|Heart Center Research, LLC|
|Huntsville, Alabama, United States, 35801|
|United States, Arkansas|
|Arkansas Heart Hospital|
|Little Rock, Arkansas, United States, 72211|
|United States, California|
|La Jolla, California, United States, 92037|
|Loma Linda University Health|
|Loma Linda, California, United States, 92354|
|Mercy Heart and Vascular Institute|
|Sacramento, California, United States, 95816|
|St. Joseph's Medical Center|
|Stockton, California, United States, 95204|
|United States, Delaware|
|Newark, Delaware, United States, 19713|
|United States, Georgia|
|Medical Center of Central Georgia|
|Macon, Georgia, United States, 31201|
|United States, Louisiana|
|Opelousas General Health System|
|Opelousas, Louisiana, United States, 70570|
|United States, Maryland|
|Baltimore, Maryland, United States, 21215|
|United States, Mississippi|
|Hattiesburg, Mississippi, United States, 39401|
|Northern Mississippi Medical Center|
|Tupelo, Mississippi, United States, 38801|
|United States, Nevada|
|St. Rose Dominican|
|Las Vegas, Nevada, United States, 89113|
|United States, Oklahoma|
|St. John Medical Center|
|Tulsa, Oklahoma, United States, 74104|
|United States, South Carolina|
|Anderson, South Carolina, United States, 29621|
|Lexington Medical Center|
|West Columbia, South Carolina, United States, 29169|
|United States, Washington|
|Franciscan Research Center|
|Tacoma, Washington, United States, 98405|
|Principal Investigator:||Mark Dorogy, MD||The Medical Center of Central Georgia|