ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System (ARISTOCRAT)
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|ClinicalTrials.gov Identifier: NCT02061696|
Recruitment Status : Terminated (Device was modified and no longer available to investigator)
First Posted : February 13, 2014
Results First Posted : August 18, 2017
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Vascular Access Device Procedure: Standard Manual Compression||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Active Comparator: Standard Manual Compression
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Procedure: Standard Manual Compression
Closure procedure by Manual Compression
Active Comparator: AXERA 2 Access System
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Device: Vascular Access Device
AXERA 2 Access System with Reduced Manual Compression
Other Name: AXERA 2 Access System
- Number of Participants With Any Site-Related Major Adverse Events [ Time Frame: Up to 37 days post procedure ]Observation of any major access site related complications (number of participants).
- AXERA 2 Access System Success [ Time Frame: 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 Hemostasis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1 day post procedure ]Time following procedural sheath removal until actual discharge.
- Time to Ambulation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 37 days post procedure ]Observation of any minor access site related complications.
- Patient Satisfaction [ Time Frame: Up to 37 days post procedure ]Assessed by a patient satisfaction questionnaire.
- Pain Score [ Time Frame: Up to 37 days post procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061696
|United States, Michigan|
|Borgess Medical Center|
|Kalamazoo, Michigan, United States, 49048|
|Principal Investigator:||Frank Saltiel, MD||Chairman, Borgess Heart Institute|