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Access Safety and Efficacy Post Endovascular Intervention (ASPEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Arstasis, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Disease. Device: Arstasis Access System (AXERA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: Procedure through 30 day follow-up. ]
    Absence of major access site-related complications.

  2. 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 :
  1. Time to Hemostasis (TTH) [ Time Frame: Immediately following procedural sheath removal. ]
    Elapsed time between sheath removal and first observed hemostasis.

  2. 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.

  3. 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.

  4. 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.

  5. Minor Adverse Events [ Time Frame: Procedure through 30 day follow-up. ]
    Combined rate of minor vascular access-site related complications.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773148


Locations
Show Show 17 study locations
Sponsors and Collaborators
Arstasis, Inc.
Investigators
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Principal Investigator: Mark Dorogy, MD The Medical Center of Central Georgia

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Responsible Party: Arstasis, Inc.
ClinicalTrials.gov Identifier: NCT01773148    
Other Study ID Numbers: RC-03773
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Cardiovascular Diseases