ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 5/25/2018 |
| Start Date: | January 2014 |
| End Date: | January 2016 |
A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
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.
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.
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.
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.
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.
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