Carotid Artery Disease
Conditions
Keywords
Carotid Artery Disease, Embolic Protection
Brief summary
The purposes of this study are: 1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. 2. To evaluate rare and unanticipated adverse events. 3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
Interventions
DEVICEPROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Carotid artery stenting with distal embolic protection.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and above * Informed consent * Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use * Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined anatomical or clinical high risk criteria
Exclusion criteria
* Subjects with contraindications as outlined in the Instructions for Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. | 30 Days | Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection. | 1,500 |
| Total | 1,500 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 54 |
| Overall Study | Exited study due to other reasons | 33 |
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | Withdrawal by Subject | 39 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 577 Participants |
| Sex: Female, Male Male | 923 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 258 / 1,500 |
| serious Total, serious adverse events | 553 / 1,500 |
Outcome results
Primary
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. | 99 participants |