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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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HERCULES PAS


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General
Application Number P110001 / PAS001
Current Plan Approved 06/26/2012
Study Name HERCULES PAS
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 Design Description 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 Description 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.
Data Collection ¿ 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

Final Study Results
Number of Patients 202
Number of Sites 37
Follow-up Rate 73%
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).

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.

Strengths & Weaknesses Strengths ¿ Outcome well below performance goal

Weakness - High attrition rate (27%).

Label Changes yes


HERCULES PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/18/2012 01/23/2012 Overdue
one year report 07/19/2012 07/18/2012 On Time
18 month report 01/17/2013 01/04/2013 On Time
two year report-FINAL 07/19/2013 04/08/2013 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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