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Access Safety and Efficacy Post Endovascular Intervention (ASPEN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Arstasis, Inc.
Sponsor:
Information provided by (Responsible Party):
Arstasis, Inc.
ClinicalTrials.gov Identifier:
NCT01773148
First received: January 15, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease.
Device: Arstasis Access System (AXERA)

Study Type: Interventional
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

Further study details as provided by Arstasis, Inc.:

Primary Outcome Measures:
  • 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 ]

    Defined as:

    • Successful placement of AXERA followed by procedural sheath
    • Achievement of hemostasis in conjunction with manual or mechanical compression


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 240
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 18 years of age or older.
  • Subject is clinically indicated for a PCI or PVI involving access through a 5F or 6F introducer sheath in the femoral artery.
  • Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) within 2 hours post procedure.
  • Female subjects of child bearing potential must have a negative pregnancy test.

Exclusion Criteria:

  • Subjects who are pregnant or lactating.
  • Subject has a pre-existing severe non-cardiac systemic disease/illness or another reason that results in a projected life expectancy of less than 1 year.
  • Subject has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
  • Subject has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mm diastolic).
  • Subject has significant bleeding coagulopathy or platelet disorder, (INR> 2.0), including known thrombocytopenia (platelet count <100,000/µL), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (hemoglobin <10 g/dL, or hematocrit <30%).
  • Subject presents with chronic renal insufficiency (creatinine ≥3.0mg/dl).
  • Subject presents with hemodynamic instability or is in need of emergent surgery or emergent procedure.
  • Subject presents with ST elevation myocardial infarction.
  • Subject presents with unstable angina or non-ST elevation myocardial infarction and has troponin level > 3 X upper limit of normal. There must be at least one troponin level drawn > 6 hours after onset of chest pain.
  • Subject has received low molecular weight heparin < 8 hours before vascular access, glycoprotein IIb/IIIa inhibitor < 24 hours before vascular access, unfractionated heparin by infusion < 1 hour before vascular access, or parenteral heparin at anticoagulant dose (as opposed to DVT prophylaxis)< 6 hours before vascular access.
  • Subjects who are clinically obese, defined as BMI >40.
  • Subject has received femoral artery Vessel Closure Implant (VCI) (suture or staple) at the target access site.
  • Subject has received femoral artery VCI (collagen/PEG/PGA) at the target access site within 90 days of AXERA procedure.
  • Subject is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize, is leg amputee or has known paralysis) or unable to ambulate within 2 hours post procedure.
  • Subject has had prior vascular surgery or vascular grafts at the target femoral artery access site.
  • Subject has had a previous target femoral artery complication from angiography (such as pseudoaneurysm, Arteriovenous (AV) fistula, dissection), small CFA, abnormal, absent or weak distal ipsilateral pulse, or presenting with clinically significant peripheral vascular disease in the vicinity of the puncture.
  • Subject has a high puncture (i.e. above the inferior reflection of the inferior epigastric artery).
  • Subject has antegrade puncture.
  • Subject has a stent in the ipsilateral common femoral artery.
  • Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773148

Contacts
Contact: Lilach Ofri 650-261-8043 lofri@Arstasis.com

Locations
United States, Alabama
Heart Center Research, LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Amy Overman, BSN RN CCRC    256-519-8306    aoverman@theheartcenter.md   
Principal Investigator: David Drenning, MD         
United States, Arkansas
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Melissa New, RN, BSN    501-614-3619    Melissa.New@arheart.com   
Principal Investigator: David Mego, MD         
United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Pamela Dumas    909-558-4000 ext 46793    PDumas@llu.edu   
Principal Investigator: Anthony Hilliard, MD         
Mercy Heart and Vascular Institute Completed
Sacramento, California, United States, 95816
St. Joseph's Medical Center Recruiting
Stockton, California, United States, 95204
Contact: Teri Kozik, PhD,RN,CCRN    209-461-5257    Teri.Kozik@DignityHealth.org   
Contact: Therese Connolly    209-461-5275    therese.connolly@dignityhealth.org   
Principal Investigator: Gurinder Grewal, MD         
United States, Delaware
Christiana Care Completed
Newark, Delaware, United States, 19713
United States, Georgia
Medical Center of Central Georgia Recruiting
Macon, Georgia, United States, 31201
Contact: Carrie Knott, RN, BSN, MPH    478-633-7628    knott.carrie@mccg.org   
Principal Investigator: Mark Dorogy, MD         
United States, Louisiana
Opelousas General Health System Completed
Opelousas, Louisiana, United States, 70570
United States, Maryland
Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Kevin Bliden, BS, MBA    410-601-4795    kbliden@lifebridgehealth.org   
Principal Investigator: Paul A Gurbel, MD         
United States, Mississippi
Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Frances Findley, RN, BSN    601-268-5794    frances.findley@hattiesburgclinic.com   
Contact: Janet Byrd, RN    601-268-5800    janet.byrd@hattiesburgclinic.com   
Principal Investigator: Robert Wilkins, MD         
Northern Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Angela Long, RN    662-377-7571    along@nmhs.net   
Contact: Marsha Jones, RN,BSN,CCRP    662-377-7456      
Principal Investigator: Barry Bertolet, MD         
United States, Nevada
St. Rose Dominican Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Christie Abano, RN    702-933-9419    cabano@hcpnv.com   
Principal Investigator: Herbert Cordero, MD         
United States, Oklahoma
St. John Medical Center Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Candida Barlow, MSN RN    918-744-2685    Candida.barlow@sjmc.org   
Principal Investigator: Robert Haas, MD         
United States, South Carolina
AnMed Health Recruiting
Anderson, South Carolina, United States, 29621
Contact: Veronica Thrasher, RN, BSN    864-512-3360    Veronica.Thrasher@anmedhealth.org   
Principal Investigator: Brent McLaurin, MD         
Lexington Medical Center Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Linda Sherriff, RN,MHA,CCRC    803-744-4909    ldsherriff@lexhealth.org   
Principal Investigator: Michael Roberts, MD         
United States, Washington
Franciscan Research Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Deborah A. Watkins, RN, MHA    253-426-6736    deborahwatkins@fhshealth.org   
Principal Investigator: Theodore Lau, MD         
Sponsors and Collaborators
Arstasis, Inc.
Investigators
Principal Investigator: Mark Dorogy, MD The Medical Center of Central Georgia
  More Information

No publications provided

Responsible Party: Arstasis, Inc.
ClinicalTrials.gov Identifier: NCT01773148     History of Changes
Other Study ID Numbers: RC-03773
Study First Received: January 15, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014