Trial Outcomes & Findings for Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF) (NCT NCT03816202)
NCT ID: NCT03816202
Last Updated: 2022-01-14
Results Overview
Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
up to 60 days post-procedure
Results posted on
2022-01-14
Participant Flow
Participant milestones
| Measure |
Sundt Carotid Shunt
Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sundt Carotid Shunt
n=100 Participants
Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 6.8 • n=100 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: up to 60 days post-procedurePopulation: number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal
Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
Outcome measures
| Measure |
Sundt Carotid Shunt
n=100 Participants
Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt
|
|---|---|
|
Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
|
3 Participants
|
Adverse Events
Sundt Carotid Shunt
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sundt Carotid Shunt
n=100 participants at risk
number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal
|
|---|---|
|
Nervous system disorders
Cerebral Ischemia Injury
|
2.0%
2/100 • Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.
|
|
Cardiac disorders
Artery injury
|
1.0%
1/100 • Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.
|
Additional Information
Andrew Tummon, Director, Global Clinical Trials
Integra LifeSciences
Phone: 609-936-5490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place