The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
351
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
The Cardiovascular Center
Parker, Arizona, United States
Sequoia Hospital
Redwood City, California, United States
P&S Surgical Hospital
Monroe, Louisiana, United States
Cardiovascular Institute of the South-Opelousas
Opelousas, Louisiana, United States
Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Time frame: Procedure through 30 days follow-up.
Major Adverse Events Reported as Percentage of Participants With Adverse Events.
Observation of any major access site-related complication (percentage of participants).
Time frame: Procedure through 30 day follow-up.
Device Success
Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.
Time frame: Procedure
Minor Adverse Events
Observation of any minor access site-related complications.
Time frame: Procedure through 30 day follow-up.
Time to Hemostasis
The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
Time frame: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
Time to Discharge Eligibility
The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.
Time frame: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
Time to Actual Discharge
The time from sheath removal to actual hospital discharge.
Time frame: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
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Willis-Knighton Hospital
Shreveport, Louisiana, United States
The Cooper Health System
Camden, New Jersey, United States
Mercy Hospital Fairfield
Fairfield, Ohio, United States
Volunteer Research Group, LLC
Knoxville, Tennessee, United States
Time to Ambulation
Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.
Time frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
Percentage of Participants With Bed Elevation Within 15 Minutes.
Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.
Time frame: Post procedure
Time to Hemostasis
Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.
Time frame: Hemostasis was evaluated immediately following procedural sheath removal.
Time to Ambulation
Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.
Time frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.