Trial Outcomes & Findings for X-Seal EU Post-Market Clinical Follow-Up Protocol (NCT NCT02406612)
NCT ID: NCT02406612
Last Updated: 2018-10-29
Results Overview
The rate of major complications within approximately 30 days following the procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
30 days
Results posted on
2018-10-29
Participant Flow
Participant milestones
| Measure |
Diagnostic
Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure.
|
Interventional
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
21
|
|
Overall Study
COMPLETED
|
22
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Diagnostic
Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure.
|
Interventional
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Overall Study
Screening Failure
|
3
|
0
|
|
Overall Study
Intra-procedural Exclusion
|
1
|
3
|
|
Overall Study
Guidewire Failure
|
0
|
1
|
Baseline Characteristics
X-Seal EU Post-Market Clinical Follow-Up Protocol
Baseline characteristics by cohort
| Measure |
Diagnostic
n=22 Participants
Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure.
|
Interventional
n=17 Participants
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 13 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ankle-Brachial Index (ABI)
|
1.1 Ratio
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.0 Ratio
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.0 Ratio
STANDARD_DEVIATION 0.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe rate of major complications within approximately 30 days following the procedure.
Outcome measures
| Measure |
Diagnostic
n=23 Participants
Patients treated with X-Seal device that were underwent a diagnostic catheter procedure.
|
Interventional
n=18 Participants
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Major Complications
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.
Outcome measures
| Measure |
Diagnostic
n=22 Participants
Patients treated with X-Seal device that were underwent a diagnostic catheter procedure.
|
Interventional
n=17 Participants
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Time-to-Hemostasis
|
0.36 Minutes
Standard Deviation 1.14
|
0.65 Minutes
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.Population: Subjects for whom ambulation data are available
The time from end of the procedure until the patient ambulates for the first time.
Outcome measures
| Measure |
Diagnostic
n=20 Participants
Patients treated with X-Seal device that were underwent a diagnostic catheter procedure.
|
Interventional
n=16 Participants
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Time-to-Ambulation
|
3.52 hours
Standard Deviation 1.09
|
3.16 hours
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 30 daysThe rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related.
Outcome measures
| Measure |
Diagnostic
n=26 Participants
Patients treated with X-Seal device that were underwent a diagnostic catheter procedure.
|
Interventional
n=21 Participants
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Adverse Events
|
2 Participants
|
8 Participants
|
Adverse Events
Diagnostic
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Interventional
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diagnostic
n=26 participants at risk
Patients treated with X-Seal device that underwent a diagnostic catheter procedure.
|
Interventional
n=21 participants at risk
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Cardiac disorders
New catheterization
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
|
Cardiac disorders
Hypertension
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
|
Endocrine disorders
Pancreatitis
|
3.8%
1/26 • 30 days post-procedure
|
0.00%
0/21 • 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
Other adverse events
| Measure |
Diagnostic
n=26 participants at risk
Patients treated with X-Seal device that underwent a diagnostic catheter procedure.
|
Interventional
n=21 participants at risk
Patients treated with X-Seal device that underwent an interventional catheter procedure.
|
|---|---|---|
|
Vascular disorders
Hematoma
|
0.00%
0/26 • 30 days post-procedure
|
14.3%
3/21 • 30 days post-procedure
|
|
Vascular disorders
Pressure at access site
|
3.8%
1/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
|
Product Issues
Guidewire tip detachment
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
|
Vascular disorders
Bleeding from contralateral access site
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
|
Vascular disorders
Pain at access site
|
0.00%
0/26 • 30 days post-procedure
|
4.8%
1/21 • 30 days post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place