Clinical trial NCT01773148: Access Safety and Efficacy Post Endovascular Intervention
Official title: AXERA Access Safety and Efficacy Post Endovascular INtervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease.
Lead sponsor: Arstasis, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Major Adverse Events
timeFrame: Procedure through 30 day follow-up.
measure: Device Success
timeFrame: Day 1-Day of Procedure.
Secondary outcomes:
measure: Time to Hemostasis (TTH)
timeFrame: Immediately following procedural sheath removal.
measure: Time to Ambulation (TTA)
timeFrame: Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated.
measure: Time to Discharge, eligibility (TTD/e)
timeFrame: Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
measure: Time to Discharge, actual (TTD/a)
timeFrame: Evaluated following procedural sheath removal until actual discharge.
measure: Minor Adverse Events
timeFrame: Procedure through 30 day follow-up.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Green
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Sacramento
country: United States
facility: Mercy Heart and Vascular Institute
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Opelousas
country: United States
facility: Opelousas General Health System
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Northern Mississippi Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: St. Rose Dominican
state: Nevada
city: Tulsa
country: United States
facility: St. John Medical Center
state: Oklahoma
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Tacoma
country: United States
facility: Franciscan Research Center
state: Washington
Study officials:
affiliation: The Medical Center of Central Georgia
name: Mark Dorogy, MD
role: PRINCIPAL_INVESTIGATOR
References: