f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • 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...


           

Cont f/u of OPTIMIZE Clinical Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number /
Requirement Number
P210014 / PAS001
Date Original Protocol Accepted 12/13/2021
Date Current Protocol Accepted  
Study Name Cont f/u of OPTIMIZE Clinical Study
Device Name SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of the the premarket cohort (OPTIMIZE Clinical Study)
Study Objective:
To assess the safety and efficacy of the Svelte DES-IDS and the Svelte DES-RX compared to control DES in subjects with = three (3) de novo coronary artery lesions in = two (2) native coronary artery vessels.
Study Design:
A prospective, single-blind, randomized, active-control, multi-center clinical study comparing the safety and efficacy of the Svelte Sirolimus-Eluting Coronary Stent Integrated Delivery System (Svelte DES-IDS) and Svelte Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System (Svelte DES-RX) to the commercially available Abbott Vascular XIENCE or Boston Scientific Promus Drug-Eluting Coronary Stents (control DES). In this study, subjects will have stents placed as the primary treatment of symptomatic ischemic heart disease.
Study Population Single-blind study with Slender IDS and Direct RX Stent Systems
Sample Size 1,645 subjects (already enrolled)
Key Study Endpoints The study primary endpoint is Target Lesion Failure (TLF) at 12 months post-procedure, defined as cardiac death, Target Vessel Myocardial Infarction (TVMI, including Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods. The Svelte DES-IDS and DES-RX investigational group will be considered safe and effective if TLF rates between it and the control DES group are shown to be non-inferior.
Follow-up Visits and Length of Follow-up 5 years


Cont f/u of OPTIMIZE Clinical Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/13/2022    
2 year report 12/13/2023    


Contact Us

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

Additional Resources

-
-