Carotid Artery Stenosis
Conditions
Brief summary
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Interventions
DEVICESundt carotid shunt
The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 18-80 years old * Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation * Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram
Exclusion criteria
* Insertion of a carotid shunt at the site of an infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal | up to 60 days post-procedure | Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sundt Carotid Shunt Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Sundt Carotid Shunt | — |
|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 6.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 63 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 3 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
Time frame: up to 60 days post-procedure
Population: number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sundt Carotid Shunt | Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal | 3 Participants |