Trial Outcomes & Findings for ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System (NCT NCT02061696)
NCT ID: NCT02061696
Last Updated: 2018-05-23
Results Overview
Observation of any major access site related complications (number of participants).
TERMINATED
NA
39 participants
Up to 37 days post procedure
2018-05-23
Participant Flow
Thirty-nine patients enrolled in the study.
Participant milestones
| Measure |
Standard Manual Compression
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression
|
AXERA 2 Access System
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
22
|
|
Overall Study
COMPLETED
|
17
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
Baseline characteristics by cohort
| Measure |
Standard Manual Compression
n=17 Participants
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression
|
AXERA 2 Access System
n=22 Participants
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 37 days post procedureObservation of any major access site related complications (number of participants).
Outcome measures
| Measure |
Standard Manual Compression
n=17 Participants
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression
|
AXERA 2 Access System
n=22 Participants
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression
|
|---|---|---|
|
Number of Participants With Any Site-Related Major Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the time of the femoral artey access procedure up to 1 hour post procedurePopulation: Data was not analyzed as the device became unavailable and the study was terminated.
Achievement of femoral artery access with AXERA and placement of procedural sheath.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From procedural sheath removal until hemostasis is achieved.Population: Data not analyzed as the test device became unavailable and the study was terminated.
Difference between the time the procedural sheath is removed and hemostasis is observed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 day post procedurePopulation: Data not analyzed as the test device became unavailable and the study was terminated.
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 day post procedurePopulation: Data not analyzed as the test device became unavailable and the study was terminated.
Time following procedural sheath removal until actual discharge.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 day post procedurePopulation: Data not analyzed as the test device became unavailable and the study was terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 minutes of successful hemostasisPopulation: Data not analyzed as the test device became unavailable and the study was terminated.
The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 days post procedurePopulation: Data not analyzed as the test device became unavailable and the study was terminated.
Observation of any minor access site related complications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 days post procedurePopulation: Data not analyzed as the test device became unavailable and the study was terminated.
Assessed by a patient satisfaction questionnaire.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 days post procedurePopulation: Data not analyzed as the test device became unavailable and the study was terminated.
Outcome measures
Outcome data not reported
Adverse Events
Standard Manual Compression
AXERA 2 Access System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Manual Compression
n=17 participants at risk
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression
|
AXERA 2 Access System
n=22 participants at risk
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression
|
|---|---|---|
|
Vascular disorders
Hematoma
|
5.9%
1/17 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Injury, poisoning and procedural complications
Discomfort and paresthesia in groin
|
0.00%
0/17
|
4.5%
1/22 • Number of events 1
|
Additional Information
Frank Saltiel, MD
Borgess Heart Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place