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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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COAST Study


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General
Application Number P040001 / PAS002
Current Plan Approved 10/24/2014
Study Name COAST Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This Medtronic Spine LLC-sponsored, prospective, multicenter longitudinal five-year study of X-STOPPK implant usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline (i.e., an indicated population) who elect to undergo X-STOPPK surgery.
Study Population Description The study population was comprised of patients aged 50 years and older who have lumbar spinal stenosis, suffers symptoms of neurogenic intermittent claudication, have moderately impaired physical function, and are able to relieve their symptoms when they bend forward or flex their spines. This device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with X-Ray, MRI, and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X-STOP is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X-STOP may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
Sample Size The sample size required within the protocol is 240 patients.
Data Collection This study was designed primarily to evaluate long-term treatment response to the X-STOPPK implant in LSS patients with moderately impaired physical function at baseline. Treatment success in an individual patient (i.e., a responder) was defined by seven separate criteria at the two-year postoperative evaluation, as follows:

Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline

Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to preoperative baseline

Patient satisfaction with treatment (defined as a Patient Satisfaction [PS] score <2.5)

No additional surgery for lumbar stenosis performed

Maintenance of distraction

No dislodgement of the implant

No device-related complications



Sustained treatment success in a responder was defined as continued success at the five-year postoperative evaluation as defined above.



Secondary endpoints included scores from the SF-36, ODI, and NRS, as well as incidence rates of adverse events, device failures, and secondary surgeries.

Follow-up Visits and Length of Follow-up Safety and effectiveness data was assessed at baseline and annually through five (5) years postoperatively. Office visits were scheduled preoperatively, and at 6 weeks and, 1, 2, 3, 4, and 5 years postoperatively. Clinical/neurological and radiographic examination was performed during each office visit. A baseline patient history (including medication usage) was taken, and concomitant medications were recorded at each postoperative follow-up visit. In addition, patients were asked to complete the following questionnaires prior to consultation with their physicians or their staff at each postoperative visit: Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and SF-36 Health Survey. At the 2-, 3-, 4- and 5-year office visit, patients were also asked two questions assessing the value of surgery and the overall improvement in the quality of life postoperatively.
Final Study Results
Interim Safety Information The mean change in baseline symptom severity score was 0.97 at 6 post-operative weeks and 1.01 at 12 post-operative months. Five study subjects experienced device migration and 2 subjects suffered spinous process fracture.
Number of Patients These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.

162 patients were enrolled.
Number of Sites These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.

20 sites participated in enrollment.
Follow-up Rate These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.

The follow-up rate of expected subjects is 91.53% and 91.67% at the 24-month and 60-month visit, respectively. The attrition rate due to death, lost to follow-up and withdrawal is 5.56% and 27.16% at the 24-month and 60-month visit, respectively.
Safety Findings These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.

Adverse Events (AEs) Summary:

Through August 15, 2014, a total of 814 adverse events were reported by 132 (81.5%) patients. The most common category of AEs was musculoskeletal and connective tissue disorders, reported by 88 (54.3%) patients and the most commonly reported adverse event was back pain, reported by 36 (22.2%) patients. Within this set of AEs, thirty-two events were reported for 18 (11.1%) patients to be implant-related while 51 events reported in 27 (16.7%) patients were classified as X-STOP procedure-related. The most frequently reported implant-related AE was device removal reported in 10 (6.2%) patients. The most frequently reported procedure-related AEs were incisional site pain in 7 (4.3%) patients, and spinal fracture in 6 (3.7%) patients.



Serious Adverse Events (SAEs) Summary:

Through August 15, 2014, a total of 210 serious adverse events have been reported by 65 (40.1%) patients. Within this set of SAEs, 26 events were reported for 15 (9.3%) patients to be implant-related while five events reported in 3 (1.9%) patients were classified as X-STOP procedure-related.



Subsequent Lumbar Surgery

There were 39 secondary surgery forms completed in thirty-two (19.8%) patients with 28 (17.3%) patients reporting X-STOP removal.



Success Rates



Overall success rates for the study participants were observed as follows:

12 months, 44.8%; 24 months, 30.9%; and 60 months, 24.2%.

Effect Findings These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.

Strengths & Weaknesses These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.

Label Changes These results are from the 96-month interim report (Aug 15, 2014) This summary is not a final analysis as the study was terminated prior to study completion due to volunatary withdrawal of the PMA by the sponsor for business reasons.



COAST Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
18 month report 05/20/2008 05/20/2008 On Time
3 year report 11/20/2008 11/20/2008 On Time
4 year report 11/20/2009 11/13/2009 On Time
5 year report 11/20/2010 09/03/2010 On Time
6 year report 11/20/2011 11/12/2010 On Time
interim report 11/20/2011 11/18/2011 On Time
7 year report 11/21/2012 11/13/2012 On Time
reporting changes 01/29/2013 01/29/2013 On Time
8 year report 11/20/2013 11/21/2013 Overdue/Received
9 year report 11/20/2014 11/19/2014 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

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