ILLUMENATE Pivotal Post-Approval Study (PAS)
Completed · Not applicable
Conditions studied: Peripheral Artery Disease
In brief
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Key facts
- Study ID
- NCT03421561
- Run by
- Spectranetics Corporation
- People needed
- 300
- Starts
- 2013-06-18
- Expected to finish
- 2020-10-06
- Last updated by the study team
- 2024-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Yuma Regional Medical Center — Yuma, Arizona, United States
- Mission Cardiovascular Research Institute — Fremont, California, United States
- Good Samaritan Hospital - Los Angeles — Los Angeles, California, United States
- Medical Center of the Rockies — Loveland, Colorado, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Cardiovascular Research of North Florida — Gainesville, Florida, United States
- Baptist Cardiac and Vascular Institute — Miami, Florida, United States
- Coastal Vascular and Interventional — Pensacola, Florida, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Northside Hospital — Atlanta, Georgia, United States
- Advocate Health and Hospitals Corporation — Oakbrook Terrace, Illinois, United States
- St. Joseph Hospital — Fort Wayne, Indiana, United States
- Central Iowa Hospital Corporation — Des Moines, Iowa, United States
- Cardiac & Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
- Metro Health Hospital — Wyoming, Michigan, United States
- Jackson Heart Clinic — Jackson, Mississippi, United States
- Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
- Mount Sinai Medical Center — New York, New York, United States
- Mission Hospital — Asheville, North Carolina, United States
- Wake Heart Research — Raleigh, North Carolina, United States
- Rex Hospital — Raleigh, North Carolina, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- OhioHealth Research Institute — Columbus, Ohio, United States
- North Ohio Research LTD. — Elyria, Ohio, United States
- Jobst Vascular Institute — Toledo, Ohio, United States
Full record on ClinicalTrials.gov
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