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Access Safety and Efficacy Post Endovascular Intervention (ASPEN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Arstasis, Inc..
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Arstasis, Inc. Identifier:
First received: January 15, 2013
Last updated: February 23, 2015
Last verified: February 2015
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: 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. ]
    Absence of major access site-related complications.

  • Device Success [ Time Frame: Day 1-Day of Procedure. ]

    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. ]
    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.

Estimated Enrollment: 240
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)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its 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
Scripps Green
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
Christiana Care
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
Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Mississippi
Hattiesburg Clinic
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
AnMed Health
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
Sponsors and Collaborators
Arstasis, Inc.
Principal Investigator: Mark Dorogy, MD The Medical Center of Central Georgia
  More Information

Responsible Party: Arstasis, Inc. Identifier: NCT01773148     History of Changes
Other Study ID Numbers: RC-03773
Study First Received: January 15, 2013
Last Updated: February 23, 2015

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on April 26, 2017