- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773148
Access Safety and Efficacy Post Endovascular Intervention (ASPEN)
February 23, 2015 updated by: Arstasis, Inc.
AXERA Access Safety and Efficacy Post Endovascular INtervention
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Huntsville, Alabama, United States, 35801
- Heart Center Research, LLC
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72211
- Arkansas Heart Hospital
-
-
California
-
La Jolla, California, United States, 92037
- Scripps Green
-
Loma Linda, California, United States, 92354
- Loma Linda University Health
-
Sacramento, California, United States, 95816
- Mercy Heart and Vascular Institute
-
Stockton, California, United States, 95204
- St. Joseph's Medical Center
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Christiana Care
-
-
Georgia
-
Macon, Georgia, United States, 31201
- Medical Center of Central Georgia
-
-
Louisiana
-
Opelousas, Louisiana, United States, 70570
- Opelousas General Health System
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Sinai Hospital
-
-
Mississippi
-
Hattiesburg, Mississippi, United States, 39401
- Hattiesburg Clinic
-
Tupelo, Mississippi, United States, 38801
- Northern Mississippi Medical Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89113
- St. Rose Dominican
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74104
- St. John Medical Center
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Health
-
West Columbia, South Carolina, United States, 29169
- Lexington Medical Center
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Franciscan Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Placement of the AXERA device in the Femoral Artery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Adverse Events
Time Frame: Procedure through 30 day follow-up.
|
Absence of major access site-related complications.
|
Procedure through 30 day follow-up.
|
Device Success
Time Frame: Day 1-Day of Procedure.
|
Defined as:
|
Day 1-Day of Procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Hemostasis (TTH)
Time Frame: Immediately following procedural sheath removal.
|
Elapsed time between sheath removal and first observed hemostasis.
|
Immediately following procedural sheath removal.
|
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.
|
Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated.
|
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.
|
Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
|
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.
|
Evaluated following procedural sheath removal until actual discharge.
|
Minor Adverse Events
Time Frame: Procedure through 30 day follow-up.
|
Combined rate of minor vascular access-site related complications.
|
Procedure through 30 day follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Dorogy, MD, The Medical Center of Central Georgia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
January 15, 2013
First Submitted That Met QC Criteria
January 18, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Estimate)
February 24, 2015
Last Update Submitted That Met QC Criteria
February 23, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-03773
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease.
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
-
Penn State UniversityAlmond Board of California; The Hershey CompanyCompletedCardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentCompleted
-
Aziyo Biologics, Inc.CompletedCardiovascular DiseaseUnited States
-
Monash UniversityCompletedCardiovascular DiseaseAustralia
Clinical Trials on Arstasis Access System (AXERA)
-
Frank SaltielBorgess Medical Center; Borgess Cardiology Group; Borgess Heart Center for ExcellenceTerminatedCoronary Artery DiseaseUnited States
-
Medtronic EndovascularActive, not recruitingAV Fistula | Fistulas Arteriovenous | Renal Disease, End Stage | Kidney Disease, End-StageUnited States
-
Transseptal Solutions Ltd.Meditrial Europe Ltd.CompletedAtrial FibrillationFrance, Germany
-
The Pelvic Floor InstituteCystosure; Innovative Research Inc.UnknownUrologic Diseases | Urinary Incontinence | Urinary Tract Infections | Pelvic Floor Disorders | Catheter-Related Infections | Catheter; Infection (Indwelling Catheter) | Urologic Injuries | Bladder Infection | Mucosal Inflammation | Mucosal Infection | Bladder Injury | Catheter ComplicationsUnited States
-
University Hospitals Cleveland Medical CenterApollo Endosurgery, Inc.CompletedGastric Disease | Colon DiseaseUnited States
-
NYU Langone HealthDepartment of Health and Human ServicesNot yet recruitingAppropriate Use of Language Across ServicesUnited States
-
Mayo ClinicRecruitingChronic Subdural HematomaUnited States
-
Rex Cancer Center, Raleigh, NCNorthwestern UniversityTerminatedChronic Phase CMLUnited States
-
Rex Cancer Center, Raleigh, NCNovartis Pharmaceuticals; Leap of Faith TechnologiesTerminated
-
Parkview HealthNot yet recruiting