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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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OSB Lead-Resolute Integrity PAS Newly Enrolled


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General
Application Number P110013 S005/ PAS001
Current Plan Approved 10/16/2014
Study Name OSB Lead-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:

Death

Myocardial Infarction

Target Lesion Revascularization (TLR)

Target Vessel Revascularization (TVR)

Stent Thrombosis

Stroke

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.



OSB Lead-Resolute Integrity PAS Newly Enrolled Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
five year report 02/21/2018    
six year report 02/22/2019    
seven year report 02/22/2020    
Final Report 12/22/2020    


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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