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NCT03455374 · ClinicalTrials.gov registry record · NA
Diamondback in Peripheral Vascular Disease
A NA study, sponsored by Arkansas Heart Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03455374: Clinical Trial NA study, sponsored by Arkansas Heart Hospital.
NCT03455374 is a NA study that was terminated before completion, run by Arkansas Heart Hospital. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03455374, a NA study, was terminated before completion, sponsored by Arkansas Heart Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcification on Computer Tomography Angiogram (PCA) or peripheral angiogram requiring percutaneous peripheral intervention (PPI).
Primary Outcome
Luminal area gain in the treated segment of the vessel wall between pre-and post-atherectomy OCT images.
Interventions
- DEVICE Treatment with CSI atherectomy device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2019-05-13 |
| Phase | NA |
Why NCT03455374 stopped before completion
NCT03455374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment with CSI atherectomy device is the first listed.
NCT03455374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03455374 about?
NCT03455374 is a clinical study titled "Diamondback in Peripheral Vascular Disease". This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcifi...
What is the current status of trial NCT03455374?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2017-08-08. Estimated completion is 2019-05-13.
What interventions are being tested in trial NCT03455374?
The interventions under investigation include: Treatment with CSI atherectomy device (DEVICE).
Who is sponsoring clinical trial NCT03455374?
This trial is sponsored by Arkansas Heart Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03455374's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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