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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140028 / PAS001 |
| Study Name |
SuperNOVA Continued f/u study
|
| Device Name |
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a continued follow-up of premarket cohorts
|
| Study Population |
Patients implanted with the Innova¿ Vascular Self-Expanding Stent System. No comparator.
|
| Sample Size |
299 subjects were previously enrolled. All subjects in active follow-up will continue through their final required follow-up visit.
|
| Key Study Endpoints |
Primary Safety Endpoint - extended
The safety endpoint assesses a composite major adverse event (MAE) rate and will be reported at 2 and 3 years post-procedure. The MAEs considered and adjudicated by the Clinical Events committee (CEC) are defined as:
o All causes of death through 1 month post-index procedure
o Target limb major amputation
o Target Lesion Revascularization (TLR)
Co-Primary Efficacy Endpoints - extended
The efficacy endpoints assess vessel primary patency as determined by Duplex Ultrasound (DUS). Primary patency will be reported at 2 years post-procedure for the core stent matrix, the long stents and the entire matrix.
o Vessel primary patency is defined as freedom from more than 50% stenosis based on DUS peak systolic velocity ratio (PSVR) comparing data within the target segment to the proximal normal arterial segment in the absence of Target Lesion Revascularization (TLR) or bypass.
o The DUS will be conducted at each site per protocol requirements and sent to an independent core laboratory for analysis.
o A systolic velocity ratio (SVR) >2.4 suggests >50% stenosis.
|
| Follow-up Visits and Length of Follow-up |
No new enrollment
Follow-up is ongoing in this study with all subjects past the 12 month visit. Office visits will continue at 2 and 3 years post-index procedure for all subjects. Additional office visits will occur at 4 and 5 years for subjects enrolled in Japan only.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
299
|
| Actual Number of Sites Enrolled |
49
|
| Patient Follow-up Rate |
A total of 299 subjects enrolled in the study. As of September 29, 2016, 295 enrolled study subjects completed the 30-day post-procedure visit, 276 subjects the 6-month follow-up visit, 266 subjects the 12-month follow-up visit, 254 subjects the 24-month follow-up visit, and 238 subjects have completed the 36-month follow-up visit.
|
| Final Safety Findings |
The primary safety endpoint of the 12-month Major Adverse Event (MAE)-free rate was met at 85.8%, above the pre-established performance goal (PG) of 59.6%.
|
| Final Effect Findings |
The primary efficacy endpoint of primary patency (peak systolic velocity ratio {PSVR} less than or equal to 2.4 in the absence of TLR) at 12 months was 66.4% for the entire matrix. The established PG was 63%.
|
| Study Strengths & Weaknesses |
The study was completed with a reasonably high rate of follow-up compliance out to 36 months. The major weakness is the large number of protocol deviations. However, as noted by the clinical reviewer these were mostly a result of missed follow-up or incomplete protocol assessments.
|
| Recommendations for Labeling Changes |
No additional information is available from these results that contradicts the information already contained in the publicly available SSED and labeling. No labeling changes are therefore recommended.
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