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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110001 / PAS001 |
| Date Original Protocol Accepted |
06/26/2012
|
| Date Current Protocol Accepted |
06/26/2012
|
| Study Name |
HERCULES PAS
|
| Device Name |
RX HERCULINK ELITE RENAL STENT SYSTEM
|
| Clinical Trial Number(s) |
NCT00490841
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The HERCULES trial is a prospective, non-randomized, multi-center, single-arm clinical trial to demonstrate efficacy and safety of the RX Herculink Elite Renal Stent System (Herculink Elite) in the treatment of suboptimal post-procedural percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic de novo or restenotic renal artery stenoses in patients with uncontrolled hypertension.
|
| Study Population |
The population is entirely comprised of the existing 202-patient HERCULES study cohort.
|
| Sample Size |
The sample size and power calculation were based on the primary endpoint of binary restenosis rate at 9 months. The OPC for the binary restenosis rate at 9 months was determined to be based on the ASPIRE-2 and SOAR clinical studies.
|
| Key Study Endpoints |
Major Adverse Events: (death, nephrectomy, embolic events resulting in kidney damage) reported for all follow up visits up to 36 months.
Target lesion revascularization (TLR) for all follow-up visits up to 36 months.
Primary patency rate at 24 and 36 months.
Secondary patency through 36 months for all visits.
Change in blood pressure, anti-hypertensive medication intake, and renal function for all follow up visits up to 36 months.
|
| Follow-up Visits and Length of Follow-up |
36 months
12 months (+/- 6 weeks)
Physician office visit: Blood pressure measurement, antihypertensive medication review, identification of adverse events, laboratory (sCr)
24 months (+/- 8 weeks)
Physician office visit: Blood pressure measurement, antihypertensive medication review, identification of adverse events, laboratory (sCr), duplex ultrasound
36 months (+/- 8 weeks)
Physician office visit: Blood pressure measurement, antihypertensive medication review, identification of adverse events, Laboratory (sCr), duplex ultrasound
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
202
|
| Actual Number of Sites Enrolled |
37
|
| Patient Follow-up Rate |
73%
|
| Final Safety Findings |
The binary restenosis rate at 9 months was 10.5% (22/209), with the upper one-sided 95% CI of
14.7%, which was significantly below the pre-specified PG of 28.6% (p < 0.0001, exact binomial
test).
|
| Final Effect Findings |
3 year rates:
The freedom from TLR Kaplan-Meier Survival Analysis was 87.6%.
The study device, procedure, and clinical success rates were high: 96.0% (237/247), 99.2% (238/240) and 98.0% (197/201), respectively.
Primary and secondary patency rates at 36 months were 82.9% and 95.8%, respectively.
There was a significant improvement in blood pressure from baseline.
There was no difference in the mean serum creatinine (sCr) and renal function from baseline.
|
| Study Strengths & Weaknesses |
Strengths - Outcome well below performance goal
Weakness - High attrition rate (27%).
|
| Recommendations for Labeling Changes |
yes
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