|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140026 / PAS001 |
| Date Original Protocol Accepted |
08/03/2015
|
| Date Current Protocol Accepted |
04/13/2017
|
| Study Name |
ROADSTER 2 Registry
|
| Device Name |
ENROUTE TRANSCAROTID STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective:
The purpose of this PAS is to further evaluate the safety and effectiveness of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique
Design:
This is an open-label, single arm, multi-center new enrollment PAS
|
| Study Population |
Patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be symptomatic (greater than or equal to 50% stenosis) or asymptomatic (greater than or equal to 80% stenosis). Patients will serve as their own comparison group.
|
| Sample Size |
A minimum of 600 newly enrolled patients from a minimum of 30 sites to a maximum of 100 sites in the US. A maximum of 30 patients per physician will be included in the first 600 patients. The sample size is based on the rate of procedural success within 30 days of the stent implant in comparison to an a priori threshold of 85% derived from the ROADSTER Study. An observed rate of procedural success greater than 89% in the ROADSTER 2
Registry will be significant with a minimum of 600 patients (at 89% success among 600 total cases, the lower binomial confidence limit would be 86.22%).
|
| Key Study Endpoints |
The primary endpoint is the rate of procedural success (defined as technical success in the absence of hierarchical stroke, death, or MI) through 30 days following stent implant.
The secondary endpoints include the following (through 30 days post index procedure):
- Acute device success defined as the ability to insert the device,
establish flow reversal, and remove the device
- Technical success, defined as acute success plus the ability to deliver interventional tools
- Rate of cranial nerve injury
- Rate of hierarchical stroke, death, or myocardial infarction (MI)
- Rate of hierarchical stroke, death or MI by symptom status
- Acute device, technical and procedural success by physician experience
- Acute device, technical and procedural success by physician training level
- Acute device, technical and procedural success by enrollment quartile.
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed for 30 days (+7 days) post index procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
692
|
| Actual Number of Sites Enrolled |
41 US; 2 OUS
|
| Patient Follow-up Rate |
ITT: 98.0% (678/692); PP: 98.9% (625/632)
|
| Final Safety Findings |
30-day MAE rate (death, stroke, MI): ITT 3.2% (22/692); PP 1.7% (11/632)
In the ITT cohort, there were ten (10) cranial nerve injuries. There were ten (10) adverse events beyond death, stroke, myocardial infarction and cranial nerve injury. Nine (9) of these events were arterial dissections (1.3%). Two (2) arterial dissections were converted to CEA (0.3%). The remaining event was stent thrombosis (0.1%).
In the Per Protocol (PP) cohort, there were eight (8) cranial nerve injuries. There were eight (8) adverse events beyond death, stroke, myocardial infarction and cranial nerve injury. Seven (7) of these events were arterial dissections (1.1%). Two (2) arterial dissections were converted to CEA (0.3%). The remaining event was stent thrombosis (0.2%).
|
| Final Effect Findings |
Procedural success: ITT: 96.5% (668/692) ; PP: 97.9% (619/632)
Procedural success is defined as technical success in the absence of hierarchical stroke, death or myocardial infarction at 30 days.
|
| Study Strengths & Weaknesses |
The strengths of the ROADSTER 2 PAS include the larger sample compared to the pivotal ROADSTER study. Acute device, technical and procedural success were presented to show operator/device interaction. Additionally, major adverse event (clinical outcomes) were analyzed in the same manner as in the pivotal ROADSTER study to demonstrate consistency of the results. All major adverse events, which are components of the primary endpoint, were independently adjudicated to ensure a lack of bias in event reporting.
The ROADSTER 2 PAS was not randomized thereby lacking a contemporaneous comparator to other carotid revascularization modalities. Enrollment was based upon pre-defined inclusion/exclusion criteria which would otherwise exclude cohorts of patients in whom the safety and efficacy was not assessed. Non-consecutive enrollment could reflect patient selection bias. Low numbers of enrolling physicians in Levels 2 and 3 potentially limit the generalizability of the results.
|
| Recommendations for Labeling Changes |
updated labeling is currently under review
|
