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

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Cont f/u of Sub in SFA Global Clin Prog


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General
Study Status Completed
Application Number P140010 / PAS002
Date Current Protocol Accepted 06/19/2015
Study Name Cont f/u of Sub in SFA Global Clin Prog
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 Prospective cohort study of the continued follow-up of patients enrolled in the IN.PACT superficial femoral artery (SFA) Global Clinical Program (premarket cohorts and the IN.PACT Global Study).

The study population includes all IN.PACT Admiral drug-coated balloon (DCB) subjects enrolled in the IN.PACT SFA Trial, the IN.PACT SFA pharmacokinetic (PK) Sub-study, and the IN.PACT Global Study.

The IN.PACT SFA Trial was designed as a two-phase, global, multicenter, single-blind, randomized (2:1 IN.PACT Admiral DCB to percutaneous transluminal angioplasty (PTA)) trial.

The IN.PACT SFA PK Sub-study was designed to characterize the concentration level and pharmacokinetic parameters of paclitaxel in the systemic circulation over time. The sub-study was conducted concurrently with the IN.PACT SFA II phase of the IN.PACT SFA Trial in the United States.

The IN.PACT SFA Global Study was designed as a prospective, multi- center, single-arm study of consecutively enrolled patients treated for atherosclerotic disease of the SFA and/or

popliteal artery (PA) with the IN.PACT Admiral DCB.



Study Population Description The study population includes all IN.PACT Admiral DCB subjects enrolled in the IN.PACT SFA Trial, the IN.PACT SFA PK Sub- study, and the IN.PACT Global Study.

Sample Size There are at least 1,600 IN.PACT Admiral DCB subjects, including 220 DCB subjects from the IN.PACT SFA Trial, 25 DCB subjects from the IN.PACT SFA PK Sub-study, and 1,400 DCB subjects from the IN.PACT Global Study.

Data Collection Key safety and effectiveness endpoints

Through 60 months

-Major Adverse Event Composite and its individual components (All-cause mortality, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, and thrombosis at the target lesion)

-Clinically-driven target lesion revascularization (CD-TLR)

-All TLR

-All TVR

-Serious Adverse Events

At 24 and 36 months

- Primary sustained clinical improvement

- Secondary sustained clinical improvement

- Quality of Life assessment

- Walking capacity

Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled Cohort Subjects Enrolled

On-Label 650

All-Subject 1651

Long Lesion 227
Actual Number of Sites Enrolled On-Label IN.PACT SFA I: The first phase of the IN.PACT Admiral

All subject DCB program completed enrollment in Europe with 13

participating clinical sites.

IN.PACT SFA II: The second phase of the IN.PACT

Admiral DCB program completed enrollment in the US with

44 participating clinical sites.

IN.PACT SFA PK Sub-study: Completed enrollment in

the US with nine participating clinical sites.

IN.PACT Global Study: Completed enrollment globally

with 64 participating clinical sites.

Long Lesion 28 non-US investigational sites
Patient Follow-up Rate Cohort Follow-up Time Overall Follow-up Compliance %

On-Label 60 Months 86.3

All-Subject 60 Months 85.1

Long Lesion 36 Months 86.7
Final Safety Findings Cohort Primary Safety Endpoint

On-Label MAE composite and its individual components (all-cause

All-Subject mortality, CD-TVR, major target limb amputation, and

thrombosis at the target lesion site), CD-TLR, all TVR, all

TLR, and serious adverse events.

Long Lesion Freedom from device and procedure-related death through 30

days post-procedure and freedom from target limb major

amputation and clinically-driven target vessel revascularization

(CD-TVR) within 12 months post-index procedure.
Final Effect Findings On-Label Primary sustained clinical improvement, secondary sustained

All-subject clinical improvement, quality of life assessment

by EQ-5D questionnaire, and walking capacity assessment by WIQ.

Long Lesion Primary patency within 12 months post-index procedure,

defined as freedom from clinically-driven target lesion

revascularization (CD-TLR), and freedom from restenosis as

determined by Doppler Ultrasound (DUS) Peak Systolic

Velocity Ratio (PSVR) less than or equal to 2.4.
Study Strengths & Weaknesses The study has a patient mortality rate of 16.1% for the Global Registry

Patients at 5 years, and 6.4% for the Long Lesion Patients at 3 years. However, safety and functional

results were as expected at these time points. Additionally, the follow-up period includes a very high

number of patients not eligible for follow-up (e.g., death, withdrawal) in the on-label and all-subject

cohorts. However, of those eligible for follow-up, the rate was 86.3% for on-label and 85.1% for the

all-subject cohort.
Recommendations for Labeling Changes No labeling changes recommended


Cont f/u of Sub in SFA Global Clin Prog Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 12/30/2015 12/18/2015 On Time
two year report 08/20/2017 08/16/2017 On Time
final report 10/01/2018 10/05/2018 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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