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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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Application Number P020026 S017/ PAS001
Current Plan Approved 10/10/2014
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, multi-center, non-randomized, postmarket surveillance study.
Study Population Description Study subjects with ischemic heart disease, due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing PCI with stent placement and no contraindications to prolonged DAPT and who have received at least one 2.25 mm CYPHER stent during the course of the study.

The study population enrolled in this postmarket surveillance study will supplement the 2.25mm CYPHER data collected from the CYPHER Elite randomized trial. The intent is to combine the data from the CYPHER Elite randomized trial to have a total sample size of 160 patients. This trial is expecting to enroll 160 subjects in which approximately 24 of the subjects will come from the CYPHER Elite trial. Subjects with de novo atherosclerotic coronary artery lesions that are treated with a 2.25mm stent will be eligible for study participation. Subjects must meet all eligibility criteria for inclusion into the study.

Sample Size A total of 160 patients with de novo coronary artery lesions that are treatable with a 2.25 mm stent and meet all other inclusion and exclusion criteria will be enrolled into this study. The clinical outcomes and safety data from this protocol will be pooled for analysis with the

2.25mm CYPHER control data from the CYPHER ELITE Stent IDE clinical study, (IDE G070140).

With a sample size of 142, a one-sided ÷2 test using a nominal significance level of 0.05 will have approximately 90% power to reject the null hypothesis when the observed CYPHER 2.25mm TLF rate at 12 months is 21.0%. Assuming a 10% attrition rate over 12 months, enrollment is set at 160 patients. The 160 patients will be a combination of those patients enrolled in this post-market study and those enrolled

in the control arm of the Cypher Elite trial.

Data Collection Primary Endpoints

The primary endpoint of this study is target lesion failure (TLF) defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a

vessel other than the target vessel at 12-months post-procedure.

Secondary Endpoints

1.Procedural endpoints:

−Lesion success

−Device success

−Procedure success

2. Clinical endpoints at 12 months post procedure and yearly to 33

months post procedure:

−Target lesion revascularization (TLR)

−Target vessel revascularization (TVR)

−Target vessel failure (TVF) and its individual components

−Composite endpoint of all deaths or MI

−Composite endpoint of cardiac death or MI

−Major adverse cardiac events (MACE) (death, Q wave or WHO-defined non-Q wave myocardial infarction, emergent bypass surgery, or repeat target lesion revascularization) and its individual components

3. Safety endpoints:

−Stent thrombosis events (acute, sub-acute, late, very late) (using both ARC and ¿Protocol¿ definition)

−Bleeding events

−Death (cardiac and non-cardiac)

−Myocardial Infarction (Q wave or WHO-defined non-Q wave)

−Stroke (hemorrhagic and non- hemorrhagic)

Follow-up Visits and Length of Follow-up All subjects enrolled in this study will be followed for 33 months. Follow- up visits are at 30 days, 6 months, one year, and annually to 33 months.
Final Study Results
Number of Patients Three hundred twenty seven subjects were enrolled (20 subjects from CYPHER ELITE and 307 subjects from CYPRESS) in the CYPRESS study 2.25mm Stent Sub-Group.
Number of Sites One hundred sixty (160) sites were approved by Cordis to participate in study. One hundred thirty-nine

(139) received IRB approval, were initiated in the clinical study, and enrolled patients.

Follow-up Rate 76.76% (251/327) through 33 months
Safety Findings Protocol-defined major bleeding occurred in 5.5% (14/255) of the patients by 33 months. Using the GUSTO definition, severe bleeding was reported in 2.4% (6/253) of all randomized patients. Using the TIMI definition, the rate of major bleeding was 3.9% (10/254) at 33 months.

A total of 5.5% (14/253) experienced all-cause death [cardiac: 3.9% (10/253); non-cardiac: 1.6% (4/253)], and 7.3% (19/259) experienced myocardial Infarction (Q wave or non-Q wave).

Effect Findings The overall TLF rate was 18.8% (49/261) comprised of clinically driven TLR rate of 13.0% (34/261), target vessel MI rate of 6.2% (16/257) and cardiac death rate of 3.6% (9/253). Note: Cardiac deaths included only cardiac deaths that were related to the target vessel or an unknown vessel.

By 33 months, MACE occurred in 21.3% (56/263) of the patients with 5.5% (14/253) experiencing all- cause death [cardiac: 3.9% (10/253); non-cardiac: 1.6% (4/253)], 7.3% (19/259) experiencing MI (Q wave or non-Q wave), 0.0% (0/253) patients undergoing emergent CABG and 13.0% (34/261) undergoing clinically driven TLR. Note: cardiac deaths include all deaths of cardiac causes including death related to

a non-target vessel and cardiac death not related to a coronary artery disease.

The overall TVF rate at 33 months was 23.7% (62/262). Through 33 months post-procedure stroke was

reported in 2.0% (5/255) of the patient. The rate of definite/probable ARC-defined stent thrombosis at

33 months was 2.4% (6/255).

Strengths & Weaknesses This study provides longer term (33 months) safety and effectiveness results of the 2.25 mm CYPHER Stent among United States patients. A weakness of the study is that lost to follow-up was less than 80%. This study confirmed the safety and effectiveness results of the premarket data on the 2.25 mm CYPHER Stent System.
Label Changes Labeling changes are not recommended since this device is no longer on the market.


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 09/18/2010 12/20/2010 Overdue/Received
2 year report 09/18/2011 09/19/2011 Overdue/Received
3 year report 09/17/2012 03/01/2013 Overdue/Received
4 year report 12/26/2013 12/23/2013 On Time
Final Report 01/10/2015 05/05/2016 Overdue/Received

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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