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NCT03943160 · ClinicalTrials.gov registry record
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 50
- Enrollment target
NCT03943160: Completed study, sponsored by Abbott Medical Devices.
NCT03943160 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03943160 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
Primary Outcome
Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.
Interventions
- DEVICE Diamondback 360 Extended Length Orbital Atherectomy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-06-11 |
| Est. Completion | 2019-12-11 |
What the finished NCT03943160 record still lists
NCT03943160 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Diamondback 360 Extended Length Orbital Atherectomy System is the first listed.
NCT03943160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03943160 about?
NCT03943160 is a clinical study titled "Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI". The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
What is the current status of trial NCT03943160?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2019-06-11. Estimated completion is 2019-12-11.
What interventions are being tested in trial NCT03943160?
The interventions under investigation include: Diamondback 360 Extended Length Orbital Atherectomy System (DEVICE).
Who is sponsoring clinical trial NCT03943160?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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