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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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ION Post Approval Study

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Application Number P100023 / PAS002
Current Plan Approved 12/18/2014
Study Name ION Post Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center cohort study
Study Population Description Newly Enrolled Post-approval Study Population

Consecutive patients who are eligible to receive a ION Stent as indicated by the product labeling will be evaluated for enrollment into the study ION US Post Approval Study (PAS). Only those participants in the PAS cohort that are identified as PERSEUS-like will contribute towards the primary endpoint and the main secondary endpoint. Data from the entire PAS cohort will be used in the additional secondary endpoints.

PERSEUS-like has been defined as all patients without acute MI, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, multivessel stenting, Reference Vessel Diameter (RVD) < 2.25 mm, RVD >

4.00 mm, lesion length > 28 mm, cardiogenic shock, acute or chronic renal function (serum creatinine > 3.0mg/dl or patient on dialysis).

PERSEUS-like TAXUS Element Population

The new PERSEUS-like ION US PAS cohort participants will be combined with the following extant cohorts of the TAXUS Element (ION) patients from the TAXUS PERSEUS Workhorse (WH) and Small Vessel (SV) Clinical Trials and the TAXUS Element PERSEUS-like patients from the TAXUS Element EU COA

study (TE-Prove). This will constitute the PERSEUS-like TAXUS Element total study population evaluated under the Primary Endpoint, Main Secondary Endpoint, and Diabetic Subset analysis.

Sample Size The ION US PAS uses data from their newly enrolled subjects and other ION


The newly enrolled ION PAS US cohort will be 1,115 subjects enrolled at up to 65

U.S. sites.

The ION population is expected to be approximately 1,901 subjects with 12- month follow-up. This includes the 1,140 ION subjects from the TAXUS PERSEUS WH and SV Clinical Trials with 12-month follow-up, 360 ION PERSEUS-like subjects from the TAXUS Element EU COA study (TE-Prove) and approximately 401 ION PERSEUS-like subjects from the ION US Post-

Approval Study.

To allow for approximately 3.5% attrition per year, 2,012 PERSEUS-like subjects will be required to provide at least 1,660 PERSEUS-like subjects through 3-year follow-up. This will include 1,166 subjects enrolled in the TAXUS PERSEUS WH and SV Clinical Trials, 400 ION PERSEUS-like subjects from the TAXUS Element EU COA study (TEProve) and approximately 446

ION PERSEUS-like subjects from the ION US Post Approval Study. Assuming that 40% of the total enrolled population is on-label subjects, a total enrollment of 1,115 subjects will be required in the ION US post-approval study.

Data Collection Primary Endpoints

The 12-month CD/MI rate for ION

Secondary Endpoints

Annual increase in Academic Research Consortium (ARC) (definite/probable) ST rate in the PERSEUS-like ION population, starting at 24 months.

Additional secondary endpoints include:

1. Stent Thrombosis (ST) rate, using Academic Research Consortium (ARC) definition (definite/probable) in the following populations: overall subject population, ION on-label subject population and off- label subject population.

2. Rate of longitudinal stent deformation.

3. Overall and ION stent-related MACE rates (cardiac death, MI, TVR).

4. Overall and ION stent-related cardiac death or MI rates.

5. Overall and ION stent-related target vessel failure (TVF) rates.

6. Overall and ION stent-related TVR rates.

7. Overall and ION stent-related cardiac death rates.

8. Overall and ION stent-related MI rates.

9. All death rates

10. Non-cardiac death rates

11. All death or MI rates

12. Historical TAXUS definition stent thrombosis rates

Follow-up Visits and Length of Follow-up 2 years

30-Day, 6-Month, and 1 and 2 Years

Final Study Results
Number of Patients A total of 1,111 subjects were enrolled in the ION post-approval study.

The ION PERSEUS-like population for the primary and primary secondary endpoint analysis (n=1,789)

comprised of 1,166 subjects enrolled in the TAXUS PERSEUS Workhorse and Small Vessel Clinical Trials,

306 ION PERSEUS-like subjects from the TAXUS Element EU COA study and 317 ION PERSEUS-like subjects from the ION US Post Approval Study.

Number of Sites 49 sites
Follow-up Rate At two years the follow-up rate was 92.26% (1025/1111).

This study was originally designed to follow-up the subjects five years post-procedure. The study follow-

up was reduced to two years post-procedure because available long-term evidence showed that the rate of late stent thrombosis for this device was not expected to substantially increase after 2 years.

Safety Findings The annual increase in Academic Research Consortium (ARC)-defined (definite/probable) stent thrombosis (ST) for the ION stent from the pooled ION PERSEUS-like subjects is 0.23% (4/1720) with an upper 1-sided 95% confidence interval of 0.37% which is less than the pre-specified performance goal of 1% (p<0.0001).

Effect Findings The overall cardiac death or myocardial infarction rate for the ION PERSEUS-like subjects is 2.3% (40/1729) with an upper one-sided 95% confidence interval of 2.9% which is less than the pre-specified performance goal (p < 0.0001).
Strengths & Weaknesses This study met its performance goals and had a large sample size. This study demonstrated that the ION Paclitaxel-Eluting Coronary Stent System had a rate of ARC-definite/probable ST to be significantly less than 1% year-to-year. The study also had a low rate of attrition, thus minimizing selection bias. Subject follow-up was only for two-years. However, this device has been assessed long-term in other studies.
Label Changes A labeling change is not recommended because the results of this post-approval study are consistent with those of the PERSEUS Clinical Trial Program. The current label of the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System includes longer-term (5 years) results on the PERSEUS Clinical Trial Program.

ION Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/21/2011 10/21/2011 On Time
1 year report 04/21/2012 04/17/2012 On Time
18 month report 10/20/2012 10/19/2012 On Time
2 year report 04/21/2013 04/17/2013 On Time
3 year report 04/21/2014 04/16/2014 On Time
resp to R16 RDEF-final report 07/15/2015 07/08/2015 On Time
Final Report 08/21/2015 03/17/2015 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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