• 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...


             

ANSWER Clinical Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number H160002 / PAS001
Study Name ANSWER Clinical Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Adjunctive Neurovascular Support for Wide-Neck Aneurysm and Reconstruction (ANSWER) (Revision E): Post-Approval Study of a 365 day follow as part of the approved ANSWER study as a condition of approval per the FDA’s 19 June 2017 HDE approval letter. The study endpoints evaluated at 1 year follow-up are neurological death or stroke, technical success, rate of aneurysm occlusion, device movement or migration, stenosis, rate of incidence of new neurological deficits, and complication rate (neurological and non-neurological).
The study endpoints identified above were reviewed and approved in the ANSWER Study Protocol under IDE # G130268. The zero to 180-day clinical data has been submitted, reviewed and approved under HDE # H160002. Per the HDE approval letter the ANSWER Study Protocol would serve as Pulsar’s Post-Approval Study Protocol
Study Population Description Subjects who met the protocol entry criteria with at least one bifurcation intracranial aneurysm that is acceptable for minimally invasive treatment who were enrolled under the ANSWER study IDE G130268
Sample Size 34 subjects
Data Collection This post-approval study progress report will provide a brief summary of the results including the 1-year follow-up.

Primary Endpoints:

Safety – neurological death or major ipsilateral stroke in downstream territory to 1 year post-procedure

Occlusion – rate of aneurysm occlusion at day zero, 180 days, and 365 days using the Raymond Scale

Technical success – device placement success and ability to retain coils within aneurysm

Additional Evaluations

Incidence of new neurological deficits

Complication rate (neurological and non-neurological)

Rate of occlusion at 365 days

Device movement or migration

Stenosis at implant site
Follow-up Visits and Length of Follow-up 1 year post implantation
Interim or Final Data Summary
Actual Number of Patients Enrolled 34
Actual Number of Sites Enrolled 10
Patient Follow-up Rate 88% (30/34)
Final Safety Findings Neurological Death or Major Ipsilateral stroke in downstream territory to 1 year post procedure: 0% (0/28)

Results for National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Score (mRS) through 365 days are below:

NIH Stroke Score Pre-Procedure n = 34 Post-Procedure n = 34 30-Day n = 34 180-Day n = 321 365-Day n = 282

0 27 29 31 29 24

1 7 4 3 2 3

2 0 1 0 0 0

3 0 0 0 0 1

4 0 0 0 1 0

>4 0 0 0 0 0

Change from Pre-Procedure

Decrease by 1 - 3 5 3 3

No Change - 30 28 28 23

Increase - 1 1 1 2

1 180-day NIHSS not done in 2 subjects: 1 due to declining health with metastatic cancer and 1 due to subject non-compliance with clinical follow-up schedule.

2 365-day NIHSS not done in 6 subjects: 1 due to subject death from metastatic cancer; 1 due to subject declining health from mass effect; 1 oversight with study team and clinic and test not performed; 3 subjects lost to follow-up at 365 days.

Note: All 4 subjects that did not have the 365-day NIHSS done due to site oversight or lost to follow- up had NIHSS scores of 0 at all timepoints through 180 days.

Table 6. Modified Rankin Scale – mRS

mRS Pre-Procedure n = 34 Post-Procedure n = 34 30-Day n = 34 180-Day n = 34 365-Day n= 301

0 20 21 20 21 18

1 14 12 12 9 8

2 0 1 1 2 1

3 0 0 1 1 1

4 0 0 0 1 1

5 0 0 0 0 1

Change from Pre-Procedure

Decrease by 1 - 4 4 3 5

No Change - 27 25 25 18

Increase - 3 5 6 7

1 365-day mRS not done in 4 subjects: 1 due to subject death from metastatic cancer; 3 due to lost to follow-up at 365 days.

Note: All 3 subjects that did not have 365-day mRS due to lost to follow-up had no change in their mRS scores from pre-procedure through 180 days.



Final Effect Findings Aneurysm Occlusion:





Table 3. Aneurysm Occlusion – Raymond Score

Raymond Score Day 0

n = 34 180 Days

n= 331 365 Days

n = 302

I 18 (53%) 20 (61%) 20 (67%)

II 9 (26%) 9 (27%) 7 (23%)

III 7 (21%) 4 (12%) 3 (10%)

I/II 27 (79%) 29 (88%) 27 (90%)

1One subject (5-004) with a carotid terminus aneurysm had a CTA at 180 days and occlusion data not available on image. Same subject died due to metastatic cancer before the 365-day visit and is not included 365-day occlusion data.

2Three (3) subjects were lost to follow-up at the 365-day visit after multiple contact attempts were made (9-003, 14-002, 14-003)



Aneurysm Occlusion by Location:



Table 4. Aneurysm Occlusion – Basilar and Carotid Terminus

Raymond Score Basilar n = 27 Carotid Terminus n = 61 Basilar n = 242 Carotid Terminus n = 61

180 Day Follow-up 365 Day Follow-up

I 15 (55%) 5 (83%) 15 (63%) 5 (83%)

II 8 (30%) 1 (17%) 6 (25%) 1 (17%)

III 4 (15%) 0 (0%) 3 (12%) 0 (0%)

I/II 23 (85%) 6 (100%) 21 (88%) 6 (100%)

1One subject (5-004) with carotid terminus aneurysm had a CTA at 180 days and occlusion data could not be determined. Same subject died due to metastatic cancer before the 365-day visit and is not included 365-day occlusion data.

2Three (3) subjects were lost to follow-up at the 365-day visit after multiple contact attempts were made (9-003, 14-002, 14-003)





Technical Success: PulseRider technical success was achieved in 100% of the 34 cases. Treating physicians were able to access the aneurysm, deploy the device at the neck, and detach the device successfully.

Study Strengths & Weaknesses Study Strengths included the use of a prospective, multi-center study design with study endpoints that included both effectiveness and safety endpoints. They study also included a Clinical Events Committee (CEC) to adjudicate reported serious adverse events and make recommendations to the Sponsor.



The study weaknesses included that it was a single arm study (non-randomized) which limits the ability to draw comparisons to alternative treatments, financial conflicts of interest as some of the investigators in the study had a significant payment from Pulsar Vascular, Inc., the study was not statistically powered for hypothesis testing of the safety and probable benefit endpoints, and the mRS was not conducted by an unblinded assessor at the 180 day or 365 day follow-up visits that can introduce bias into this measurement.

Recommendations for Labeling Changes The revised labeling should include a new section of the label that reflects long-term data from the Post-Approval Study. The labeling supplement should include a summary of the post-approval study design, results, and study strengths and limitations


ANSWER Clinical Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/26/2018 01/12/2018 On Time
one year report 06/19/2018 06/19/2018 On Time


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

Related Links

-
-