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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: Completed NA study, sponsored by Spectranetics Corporation.
NCT03421561 is a NA study that has completed, run by Spectranetics Corporation. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
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 |
What the finished NCT03421561 record still lists
NCT03421561 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03421561's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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