Access Safety and Efficacy Post Endovascular Intervention (ASPEN)
The goal of this study is to assess the safety and effectiveness of the AXERA Access System in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F introducer sheath.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AXERA Access Safety and Efficacy Post Endovascular INtervention|
- Major Adverse Events [ Time Frame: Procedure through 30 day follow-up. ] [ Designated as safety issue: Yes ]Absence of major access site-related complications.
- Device Success [ Time Frame: Day 1-Day of Procedure. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]Elapsed time between sheath removal and the actual time when subject is discharged.
- Minor Adverse Events [ Time Frame: Procedure through 30 day follow-up. ] [ Designated as safety issue: Yes ]Combined rate of minor vascular access-site related complications.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|