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NCT03421561 · ClinicalTrials.gov registry record · NA
ILLUMENATE Pivotal Post-Approval Study (PAS)
A NA study, sponsored by Spectranetics Corporation.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT03421561 is a NA study that has completed, run by Spectranetics Corporation. The registered enrollment target is 300 participants.
The verdict
NCT03421561, a NA study, has completed, sponsored by Spectranetics Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
- DEVICE EverCross™ 0.035 PTA Balloon Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-06-18 |
| Est. Completion | 2020-10-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03421561
The ClinicalTrials.gov registry entry for NCT03421561 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectranetics Corporation, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is the first listed.
NCT03421561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03421561 about?
NCT03421561 is a clinical study titled "ILLUMENATE Pivotal Post-Approval Study (PAS)". 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...
What is the current status of trial NCT03421561?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2013-06-18. Estimated completion is 2020-10-06.
What interventions are being tested in trial NCT03421561?
The interventions under investigation include: Stellarex 0.035" OTW Drug-coated Angioplasty Balloon (DEVICE), EverCross™ 0.035 PTA Balloon Catheter (DEVICE).
Who is sponsoring clinical trial NCT03421561?
This trial is sponsored by Spectranetics Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
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