• 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...


           

DISRUPT CAD III Cont f/u Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number P200039 / PAS002
Date Current Protocol Accepted 04/09/2021
Study Name DISRUPT CAD III Cont f/u Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Study Design: The overall study design for the CFS is unchanged from the pivotal portion of the IDE study.



The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System in de novo, calcified, stenotic coronary arteries prior to stenting.

Disrupt CAD III will be conducted as a staged pivotal study. During the first stage, up to 25 sites in the United States will be initiated to enroll up to 75 subjects (25 roll-in, 50 pivotal). Sites outside of the US may be initiated during the initial stage and do not count toward the 25 site limit or the 75 subject limit. The first 30 pivotal subjects enrolled in the study will be included in the safety assessment and their data analyzed. Results of this early safety analysis will be sent to the FDA as an IDE supplement with a request to expand the study to 50 sites worldwide. The first 25 US sites will continue to enroll up to a total of 75 subjects during FDA’s review of this IDE Supplement.

Study Population Description The study population for the Disrupt CAD III CFS is comprised of the 384 pivotal subjects enrolled in the Disrupt CAD III IDE study. Subjects in the IDE were enrolled per eligibility criteria outlined in Section 7.2. There are no new enrollments in the Disrupt CAD III CFS.
Sample Size The process for the original sample size determination is outlined in Section 9.2. There are no new enrollments required for the CFS and no new hypothesis testing.
Data Collection The primary safety endpoint for the CFS is freedom from MACE at 12 and 24 months, reported descriptively.



Other endpoints to be assessed through 2 years post-procedure include the rate of: (1) target lesion failure (TLF) and (2) all death, cardiac death, MI, TV-MI, nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) at 6, 12 and 24 months.

Robust independent adjudication of events (i.e., Clinical Events Committee) will be maintained throughout the CFS, unmodified from the pivotal portion of the study.

Follow-up Visits and Length of Follow-up Follow-up within 12-24 hours post procedure or at discharge; follow-up at 30 days; follow-up at 6, 12, 24 months


DISRUPT CAD III Cont f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/13/2021    
one year report 02/12/2022    
18 month report 08/13/2022    
two year report 02/12/2023    
three year report 02/12/2024    


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

-
-