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NCT03241459 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
A NA study, sponsored by SurModics.
- Completed
- Registry status
- NA
- Development phase
- 446
- Enrollment target
NCT03241459: Completed NA study, sponsored by SurModics.
NCT03241459 is a NA study that has completed, run by SurModics. The registered enrollment target is 446 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03241459, a NA study, has completed, sponsored by SurModics.
- COMPLETED
- Registry status
- NA
- Development phase
- 446 participants
- Enrollment target
Study Summary
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
Primary Outcome
Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \[DUS\] peak systolic velocity ratio \[PSVR\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.
Interventions
- DEVICE Surmodics SurVeil DCB
- DEVICE Medtronic IN.PACT Admiral DCB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2024-09-17 |
| Phase | NA |
What the finished NCT03241459 record still lists
NCT03241459 is an interventional study that assigns participants to a tested intervention. The registered 446 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 (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Surmodics SurVeil DCB is the first listed.
NCT03241459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03241459 about?
NCT03241459 is a clinical study titled "Safety and Efficacy of the SurVeil™ Drug-Coated Balloon". To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
What is the current status of trial NCT03241459?
This trial is currently completed. It is a NA study. The enrollment target is 446 participants. The study started on 2017-10-23. Estimated completion is 2024-09-17.
What interventions are being tested in trial NCT03241459?
The interventions under investigation include: Surmodics SurVeil DCB (DEVICE), Medtronic IN.PACT Admiral DCB (DEVICE).
Who is sponsoring clinical trial NCT03241459?
This trial is sponsored by SurModics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03241459's enrollment target sits among peer trials
446 233rd of 2000 higher than 1,768 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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