FDA and Sponsor closed trial. New post-marketing approval trial in development.
ASCEND
A 2 and 5 Year Comparative Evaluation of Clinical Outcomes in the Treatment of Moderate Lumbar Spinal Stenosis With the Superion® Indirect Decompression System (IDS) vs. Direct Decompression Surgery for FDA Actual Conditions of Use Study
Sponsor study identifier
interventional
0
1 country
5
Study Start
February 8, 2017
Actual (reported)Primary Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2017
Actual (reported)February 8, 2017
Actual (reported)February 9, 2017
Actual (reported)July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Composite Endpoint (Primary)
Subjects in each arm (Superion® IDS and direct decompression) will be evaluated for success at each follow-up interval
60 Months
Zurich Claudication Questionnaire (ZCQ)
Clinically significant improvement in outcomes compared to baseline
60 Months
No re-operations, revisions, removals, or supplemental fixation at the index level(s)
Review in outcomes compared to baseline
60 Months
Epidural steroid injections for the treated level(s)
Review in outcomes compared to baseline
60 Months
Superion® IDS surgical procedure
Open, direct decompression surgical procedure
Device is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve
A surgical procedure - the control
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35335, United States
Coastal Pain Spinal Diagnostics
Carlsbad, California, 92009, United States
Lake Nona Medical Arts
Celebration, Florida, 32827, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Rothman Institute
Willow Grove, Pennsylvania, 19090, United States
0 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2017
First Posted
February 9, 2017
Study Start
February 8, 2017
Actual (reported)Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Contact the study team to confirm eligibility.
Primary Completion
July 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 12, 2019
Record last verified: 2019-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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