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:||January 2015|
|Estimated Primary Completion Date:||November 2014 (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.
|Contact: Debra Cogan||650-261-8073||dcogan@Arstasis.com|
|Contact: Lilach Ofri||650-261-8043||lofri@Arstasis.com|
|United States, Alabama|
|Heart Center Research, LLC||Recruiting|
|Huntsville, Alabama, United States, 35801|
|Contact: Amy Overman, BSN RN CCRC 256-519-8306 email@example.com|
|Principal Investigator: David Drenning, MD|
|United States, California|
|Mercy Heart and Vascular Institute||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Sarah Bordash, RN, BSN 916-453-4493 firstname.lastname@example.org|
|Principal Investigator: Arvin Arthur, MD|
|United States, Delaware|
|Newark, Delaware, United States, 19713|
|Contact: Desiree Hodges, RN, BSN, MBA 302-733-4112 DHodges@Christianacare.org|
|Principal Investigator: Michael E Stillabower, MD|
|United States, Georgia|
|Medical Center of Central Georgia||Recruiting|
|Macon, Georgia, United States, 31201|
|Contact: Carrie Knott, RN, BSN, MPH 478-633-7628 email@example.com|
|Principal Investigator: Mark Dorogy, MD|
|United States, Louisiana|
|Opelousas General Health System||Recruiting|
|Opelousas, Louisiana, United States, 70570|
|Contact: Lacey Huffman, LPN/CRC 337-407-3203 firstname.lastname@example.org|
|Principal Investigator: Kalyan Veerina, MD|
|United States, Maryland|
|Baltimore, Maryland, United States, 21215|
|Contact: Kevin Bliden, BS, MBA 410-601-4795 email@example.com|
|Principal Investigator: Paul A Gurbel, MD|
|United States, Mississippi|
|Hattiesburg, Mississippi, United States, 39401|
|Contact: Frances Findley, RN, BSN 601-268-5794 firstname.lastname@example.org|
|Contact: Janet Byrd, RN 601-268-5800 email@example.com|
|Principal Investigator: Robert Wilkins, MD|
|Northern Mississippi Medical Center||Recruiting|
|Tupelo, Mississippi, United States, 38801|
|Contact: Angela Long, RN 662-377-7571 firstname.lastname@example.org|
|Contact: Marsha Jones, RN, BSN, CCRP 662-377-7456|
|Principal Investigator: Barry Bertolet, MD|
|United States, Oklahoma|
|St. John Medical Center||Recruiting|
|Tulsa, Oklahoma, United States, 74104|
|Contact: Candida Barlow, MSN RN 918-744-2685 Candida.email@example.com|
|Principal Investigator: Robert Haas, MD|
|United States, Washington|
|Franciscan Research Center||Recruiting|
|Tacoma, Washington, United States, 98405|
|Contact: Deborah A. Watkins, RN, MHA 253-426-6736 firstname.lastname@example.org|
|Principal Investigator: Theodore Lau, MD|
|Principal Investigator:||Mark Dorogy, MD||The Medical Center of Central Georgia|