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

Not Applicable

Terminated

Conditions: Coronary Artery Disease

Interventions: Device: Vascular Access Device
Procedure: Standard Manual Compression

Registration Number: NCT02061696

Lead Sponsor: Frank Saltiel

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXERA 2 Access System	Vascular Access Device	The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Standard Manual Compression	Standard Manual Compression	Standard manual compression at the access site applied as per standard of care protocol for sheath removal.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Site-Related Major Adverse Events	Up to 37 days post procedure	Observation of any major access site related complications (number of participants).

Secondary Outcome Measures

Name	Time	Method
Time to Hemostasis	From procedural sheath removal until hemostasis is achieved.	Difference between the time the procedural sheath is removed and hemostasis is observed.
Time to Discharge Eligibility	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.
Time to Actual Discharge	Up to 1 day post procedure	Time following procedural sheath removal until actual discharge.
AXERA 2 Access System Success	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.
Time to Ambulation	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.
Ability to Sit up at 45-degree Angle	15 minutes of successful hemostasis	The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
Minor Access Site Related Complications	Up to 37 days post procedure	Observation of any minor access site related complications.
Patient Satisfaction	Up to 37 days post procedure	Assessed by a patient satisfaction questionnaire.
Pain Score	Up to 37 days post procedure