Stroke
Conditions
Brief summary
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
Interventions
cerebral embolic protection system
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access * Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery. * Subject (or legal representative) provides written informed consent.
Exclusion criteria
* Subject has arterial stenosis \>70% in either the left common carotid artery or the brachiocephalic artery. * Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium. * Subject has compromised blood flow to the right upper extremity. * Subject has access vessels with excessive tortuosity. * Subject has uncorrected bleeding disorders. * Subject is contraindicated for anticoagulant and antiplatelet therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) | <=72 hours | All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions. |
Countries
Australia, Denmark, France, Germany, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAVR With Sentinel Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Sentinel® Cerebral Protection System: cerebral embolic protection system | 1,501 |
| TAVR Without Sentinel Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System. | 1,499 |
| Total | 3,000 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 11 | 7 |
| Overall Study | Not described | 2 | 0 |
| Overall Study | Physician Decision | 10 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | TAVR Without Sentinel | TAVR With Sentinel | Total |
|---|---|---|---|
| Age, Continuous | 78.9 years STANDARD_DEVIATION 7.8 | 78.9 years STANDARD_DEVIATION 8 | 78.9 years STANDARD_DEVIATION 7.9 |
| Native/Non-Native Calcification Severity (site reported): Severe/Extreme | 792 Participants | 773 Participants | 1565 Participants |
| Native/Non-Native Valve Calcification Severity (site reported): Moderate | 426 Participants | 418 Participants | 844 Participants |
| Native/Non-Native Valve Calcification Severity (site reported): None/Mild | 223 Participants | 241 Participants | 464 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants | 14 Participants | 30 Participants |
| Race/Ethnicity, Customized Black or African Heritage | 25 Participants | 31 Participants | 56 Participants |
| Race/Ethnicity, Customized Caucasian | 872 Participants | 852 Participants | 1724 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 35 Participants | 53 Participants | 88 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Disclosed | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Female | 566 Participants | 631 Participants | 1197 Participants |
| Sex: Female, Male Male | 933 Participants | 870 Participants | 1803 Participants |
| Surgical Risk (Per Heart Team): Extreme/High Risk | 456 Participants | 457 Participants | 913 Participants |
| Surgical Risk (Per Heart Team): Intermediate Risk | 512 Participants | 499 Participants | 1011 Participants |
| Surgical Risk (Per Heart Team): Low Risk | 531 Participants | 545 Participants | 1076 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 1,501 | 7 / 1,499 |
| other Total, other adverse events | 0 / 1,501 | 0 / 1,499 |
| serious Total, serious adverse events | 285 / 1,501 | 315 / 1,499 |
Outcome results
Primary
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
Time frame: <=72 hours
Population: Intent-to-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVR With Sentinel | The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) | 34 Participants |
| TAVR Without Sentinel | The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) | 43 Participants |