• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail

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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


Resolute Integrity PAS Newly Enrolled

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Completed
Application Number P110013 S005/ PAS001
Date Current Protocol Accepted 10/16/2014
Study Name Resolute Integrity PAS Newly Enrolled
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a sub-study of the ongoing Resolute Integrity PAS, ordered for P110013, which is a prospective, multi-center, non- randomized, single-arm, open-label study.

To assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in two groups of patients, specifically those patients receiving stents ¡Ü 30 mm in length, referred to as the Primary Enrollment Group (PEG) and those patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Sub-study (XL Sub-study).

Study Population Description Patients who met the inclusion/exclusion criteria for the

RESOLUTE INTEGRITY US (RI-US) - XL, evaluating the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries (Overall Study and Sub-study). The subjects enrolled with the 34mm or 38mm length stents will comprise the ¡°Extended Length Sub-study (XL) - New Enrollment Cohort¡±.

Sample Size The observed event rate for the primary endpoints is assumed to

be 3.5% so a sample size of 50 subjects will provide a 95% confidence interval [0.3%, 13.0%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of

56 patients will be conservatively enrolled in this trial to ensure that at least 50 patients will be evaluable at 12 months. Centers are allowed to enroll a maximum of sixteen (16) XL Sub-study patients per center or until study enrollment has been completed, whichever comes first.

Data Collection Primary Endpoint

The primary endpoint for all patients enrolled in this study (overall and sub-study) is the composite rate of cardiac death and target vessel myocardial infarction (MI) at 12 months

Secondary Endpoints

Composite endpoints:

Major Adverse Cardiac Events (MACE)

Target Lesion Failure (TLF)

Target Vessel Failure (TVF)

Cardiac Death and Target Vessel MI

Clinical endpoints:


Myocardial Infarction

Target Lesion Revascularization (TLR)

Target Vessel Revascularization (TVR)

Stent Thrombosis


Bleeding complications in general

Dual antiplatelet therapy (DAPT) compliance

In addition, the following will be assessed:

Procedural success

Device success

Lesion success
Follow-up Visits and Length of Follow-up The length of follow-up is 5 years.

Frequency of Follow-up Assessments: 30 days, 6 months, 24 months and annually at 3, 4, and 5 years post procedure.

The patient must return to the site where the procedure was performed for a clinic visit and 12-lead ECG at 12 months. The expected length of time for enrollment is approximately 24 months. The total time for the duration from first-subject enrolled to last-subject follow-up complete is approximately 7 years.

Interim or Final Data Summary
Actual Number of Patients Enrolled 56 subjects
Actual Number of Sites Enrolled 14 sites
Patient Follow-up Rate 96.3% (54/56) at 3-years
Final Safety Findings The primary endpoint of the Resolute Integrity US Extended Length (XL) Sub-Study was the composite rate of cardiac death and target vessel myocardial infarction (TVMI) at 12-months. The primary endpoint was observed in 7.4% (4/54, 95% CI:2.1%, 17.9%) of the population. The key secondary endpoints based on the ITT population through three (3) years are as follows:

MACE (Death, Myocardial Infarction, emergent coronary bypass surgery, or repeat TLR): 17.9% (10/56)

Target Lesion Failure (Cardiac Death, TVMI, Clinically Driven TLR): 10.7% (6/56)

Target Vessel Failure (Cardiac Death, TVMI, Clinically Driven TVR): 12.5% (7/56)

All Death: 3.6% (2/56)

TVMI: 5.4% (3/56)

Clinically Driven Target Lesion Revascularization: 5.4% (3/56)

Clinically Driven Target Vessel Revascularization: 7.1% (4/56)

Stent Thrombosis (ARC Definite/Probable): 2.0% (1/51)
Final Effect Findings Lesion Success, defined as the attainment of <50% residual stenosis of the target lesion using any percutaneous method, was obtained in 100.0% (67/67) of lesions. Device Success, defined as the attainment of <50% residual stenosis of the target lesion using only the assigned device, was achieved in 97.0% (65/67) of lesions. Procedural Success, defined as <50% residual stenosis and no in-hospital MACE, was achieved in 98.2% (55/56) subjects.
Study Strengths & Weaknesses Strengthes: The RESOLUTE INTEGRITY US Extended Length (XL) Sub-Study was a prospective, open-label, multicenter study. The study achieved a follow-up rate greater than 90% at 3 years. An independent clinical event committee performed adjudication of the safety endpoints including all cases of death, Q-wave myocardial infarction (QMI), non-Q-wave MI (NQMI), stent thrombosis, target lesion revascularization and target vessel revascularization.

Weakness: The sub-study is limited by the small sample size such that any further subgroup analysis can, at best, be considered exploratory.
Recommendations for Labeling Changes The sponsor will be requested to add the complete 36-month follow-up data to the labeling.

Resolute Integrity PAS Newly Enrolled Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/23/2013 11/07/2013 Overdue/Received
one year report 02/22/2014 02/18/2014 On Time
18 month report 08/23/2014 08/22/2014 On Time
two year report 02/22/2015 02/20/2015 On Time
three year report 02/22/2016 02/22/2016 On Time
four year report 02/21/2017 02/21/2017 On Time
five year report 02/21/2018 02/16/2018 On Time
Final Report 02/22/2019 02/22/2019 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Related Links