Trial Outcomes & Findings for Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia (NCT NCT00869375)
NCT ID: NCT00869375
Last Updated: 2014-07-21
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
24 hours after the procedure
Results posted on
2014-07-21
Participant Flow
Participant milestones
| Measure |
CLEARWAY GROUP
3 patients were randomized in this group.
|
ANGIOJET GROUP
3 patients were randomized in this group
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
Baseline characteristics by cohort
| Measure |
CLEARWAY GROUP
n=3 Participants
3 patients were randomized in this group.
|
ANGIOJET GROUP
n=3 Participants
3 patients were randomized in this group
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
63 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diabetes
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Hypertension
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Dyslipidemia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Current smokers
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the procedureOutcome measures
| Measure |
CLEARWAY GROUP
n=3 Participants
No patients had distal embolization
|
ANGIOJET GROUP
n=3 Participants
No patients had distal embolization
|
|---|---|---|
|
Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 24 hours after the procedureOutcome measures
| Measure |
CLEARWAY GROUP
n=3 Participants
No patients had distal embolization
|
ANGIOJET GROUP
n=3 Participants
No patients had distal embolization
|
|---|---|---|
|
Incidence of Bleeding Complications
|
0 participants
|
0 participants
|
Adverse Events
CLEARWAY GROUP
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
ANGIOJET GROUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLEARWAY GROUP
n=3 participants at risk
4 patients were randomized in this group. One patient was excluded since intervention was not required.
|
ANGIOJET GROUP
n=3 participants at risk
3 patients were randomized in this group
|
|---|---|---|
|
Vascular disorders
Emergency surgery
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place