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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
39
AXERA 2 Access System with Reduced Manual Compression
Closure procedure by Manual Compression
Borgess Medical Center
Kalamazoo, Michigan, United States
Number of Participants With Any Site-Related Major Adverse Events
Observation of any major access site related complications (number of participants).
Time frame: Up to 37 days post procedure
AXERA 2 Access System Success
Achievement of femoral artery access with AXERA and placement of procedural sheath.
Time frame: At the time of the femoral artey access procedure up to 1 hour post procedure
Time to Hemostasis
Difference between the time the procedural sheath is removed and hemostasis is observed.
Time frame: From procedural sheath removal until hemostasis is achieved.
Time to Discharge Eligibility
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Time frame: Up to 1 day post procedure
Time to Actual Discharge
Time following procedural sheath removal until actual discharge.
Time frame: Up to 1 day post procedure
Time to Ambulation
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.
Time frame: Up to 1 day post procedure
Ability to Sit up at 45-degree Angle
The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
Time frame: 15 minutes of successful hemostasis
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Minor Access Site Related Complications
Observation of any minor access site related complications.
Time frame: Up to 37 days post procedure
Patient Satisfaction
Assessed by a patient satisfaction questionnaire.
Time frame: Up to 37 days post procedure
Pain Score
Time frame: Up to 37 days post procedure