A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System (RECITAL)
|ClinicalTrials.gov Identifier: NCT01271946|
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : January 17, 2013
Last Update Posted : January 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer||Device: Diagnostic catheterization procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Device: Diagnostic catheterization procedure
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
- 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. [ Time Frame: Procedure through 30 day follow-up. ]Observation of any major access site-related complication (percentage of participants).
- Device Success [ Time Frame: Procedure ]Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.
- Minor Adverse Events [ Time Frame: Procedure through 30 day follow-up. ]Observation of any minor access site-related complications.
- Time to Hemostasis [ Time Frame: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved. ]The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
- Time to Discharge Eligibility [ Time Frame: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site. ]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 to Actual Discharge [ Time Frame: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours. ]The time from sheath removal to actual hospital discharge.
- Time to Ambulation [ Time Frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. ]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.
- Percentage of Participants With Bed Elevation Within 15 Minutes. [ Time Frame: Post procedure ]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 to Hemostasis [ Time Frame: Hemostasis was evaluated immediately following procedural sheath removal. ]Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.
- Time to Ambulation [ Time Frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. ]Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271946
|United States, Arizona|
|The Cardiovascular Center|
|Parker, Arizona, United States, 85344|
|United States, California|
|Redwood City, California, United States, 94062|
|United States, Louisiana|
|P&S Surgical Hospital|
|Monroe, Louisiana, United States, 71201|
|Cardiovascular Institute of the South-Opelousas|
|Opelousas, Louisiana, United States, 70570|
|Shreveport, Louisiana, United States, 71103|
|United States, New Jersey|
|The Cooper Health System|
|Camden, New Jersey, United States, 08103|
|United States, Ohio|
|Mercy Hospital Fairfield|
|Fairfield, Ohio, United States, 45014|
|United States, Tennessee|
|Volunteer Research Group, LLC|
|Knoxville, Tennessee, United States, 37920|
|Principal Investigator:||Zoltan Turi, MD||The Cooper Health System|
|Principal Investigator:||John Held, MD||Mercy Hospital Fairfield|
|Principal Investigator:||Frank Kresock, MD||The Cardiovascular Center|
|Principal Investigator:||Tom Hinohara, MD||Sequoia Hospital|
|Principal Investigator:||Dale Wortham, MD||Volunteer Research Group, LLC|
|Principal Investigator:||Greg Sampognaro, MD||P&S|
|Principal Investigator:||Ray Smith, MD||Ark-La-Tex Cardiology/Willis-Knighton Hospital|
|Principal Investigator:||Kalyan Veerina, MD||Cardiovascular Institute of the South-Opelousas|