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ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System (ARISTOCRAT)

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ClinicalTrials.gov Identifier: NCT02061696
Recruitment Status : Terminated (Device was modified and no longer available to investigator)
First Posted : February 13, 2014
Results First Posted : August 18, 2017
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
Borgess Medical Center
Borgess Cardiology Group
Borgess Heart Center for Excellence
Information provided by (Responsible Party):
Frank Saltiel, Borgess Research Institute

Brief Summary:
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Vascular Access Device Procedure: Standard Manual Compression Not Applicable

Detailed Description:

The study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and PCI.

It is anticipated that the enrollment period for this study will be two years.

The post procedure follow up period is up to 37 days following the procedure.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Active Comparator: Standard Manual Compression
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Procedure: Standard Manual Compression
Closure procedure by Manual Compression

Active Comparator: AXERA 2 Access System
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Device: Vascular Access Device
AXERA 2 Access System with Reduced Manual Compression
Other Name: AXERA 2 Access System




Primary Outcome Measures :
  1. Number of Participants With Any Site-Related Major Adverse Events [ Time Frame: Up to 37 days post procedure ]
    Observation of any major access site related complications (number of participants).


Secondary Outcome Measures :
  1. AXERA 2 Access System Success [ Time Frame: At the time of the femoral artey access procedure up to 1 hour post procedure ]
    Achievement of femoral artery access with AXERA and placement of procedural sheath.

  2. Time to Hemostasis [ Time Frame: From procedural sheath removal until hemostasis is achieved. ]
    Difference between the time the procedural sheath is removed and hemostasis is observed.

  3. Time to Discharge Eligibility [ Time Frame: Up to 1 day post procedure ]
    The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.

  4. Time to Actual Discharge [ Time Frame: Up to 1 day post procedure ]
    Time following procedural sheath removal until actual discharge.

  5. Time to Ambulation [ Time Frame: Up to 1 day post procedure ]
    Time from sheath removal until the participant can stand or walk 20 feet without rebleeding. Ambulation can be evaluated at 1,2, and 4 hours post sheath removal until the participant can ambulate.

  6. Ability to Sit up at 45-degree Angle [ Time Frame: 15 minutes of successful hemostasis ]
    The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.

  7. Minor Access Site Related Complications [ Time Frame: Up to 37 days post procedure ]
    Observation of any minor access site related complications.

  8. Patient Satisfaction [ Time Frame: Up to 37 days post procedure ]
    Assessed by a patient satisfaction questionnaire.

  9. Pain Score [ Time Frame: Up to 37 days post procedure ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is between 18 and 85 years of age.
  • Cardiac catheterization procedure is indicated with involving access through a 5 French (F) or 6 French (F) introducer in the femoral artery.
  • Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
  • Subject or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis)
  • Subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure).
  • Subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction.
  • Extensive calcification of the femoral artery as see on fluoroscopy.
  • Subject has systemic hypertension unresponsive to treatment (>180mm Hg systolic and >110mm Hg diastolic).
  • Subject has received thrombolytic therapy within the 72 hours prior to catheterization.
  • Subject has known bleeding disorder,such as Factor 5 deficiency, Idiopathic thrombocytopenic purpura (ITP), thrombasthenia, Von Willebrand's disease.
  • Is on warfarin with an International Ratio (INR)>1.5.
  • Platelet count is < 100,000.
  • Anemia (Hemoglobin <10 g/dl or Hematocrit<30%).
  • Subject has compromised femoral artery access site.
  • Subject procedure requires an introducer sheath size of > 6 French (F).
  • Subject has had prior vascular surgery or vascular grafts at the femoral artery access site.
  • Subject presents with hemodynamic instability or is in need of emergent surgery.
  • Subject has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days.
  • Subject has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of < 1 year.
  • Subject is participating in an investigational drug or another device research study that interferes with the current research study endpoints.
  • Pregnant or lactating subjects.

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): NCT02061696


Locations
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United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
Sponsors and Collaborators
Frank Saltiel
Borgess Medical Center
Borgess Cardiology Group
Borgess Heart Center for Excellence
Investigators
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Principal Investigator: Frank Saltiel, MD Chairman, Borgess Heart Institute

Publications:
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Responsible Party: Frank Saltiel, Borgess Heart Institute, Chairman, Borgess Research Institute
ClinicalTrials.gov Identifier: NCT02061696     History of Changes
Other Study ID Numbers: BRI-001
First Posted: February 13, 2014    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: May 23, 2018
Last Verified: April 2018

Keywords provided by Frank Saltiel, Borgess Research Institute:
Coronary Artery Disease
Coronary Disease
Heart disease
Cardiovascular Diseases
Arteriosclerosis
Atherosclerosis
Manual Compression

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases