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NCT02085551 · ClinicalTrials.gov registry record · NA
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
A NA study of Peripheral Arterial Occlusion or Emboli, sponsored by Penumbra.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
- 5
- Study locations
NCT02085551: Completed NA study of Peripheral Arterial Occlusion or Emboli, sponsored by Penumbra.
NCT02085551 is a NA study of Peripheral Arterial Occlusion or Emboli that has completed, run by Penumbra. The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02085551, a NA study of Peripheral Arterial Occlusion or Emboli, has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.
Primary Outcome
Proportion of patients with a post-procedure TIMI score of 2 to 3.
Conditions Studied
Interventions
- DEVICE Mechanical Thrombectomy by the Indigo System
Study Locations (5)
California
- Tri-City Medical Center - San Diego
Florida
- Baptist Health South Florida - Miami
Illinois
- Rush University Medical Center - Chicago
North Carolina
- Carolinas Medical Center - Charlotte
North Dakota
- Sanford Medical Center - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT02085551 record still lists
NCT02085551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Peripheral Arterial Occlusion or Emboli appearing as the primary indexed condition, and to 1 intervention - of which Mechanical Thrombectomy by the Indigo System is the first listed.
NCT02085551 lists 5 locations in 5 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT02085551 about?
NCT02085551 is a clinical study titled "Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery". The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, ...
What is the current status of trial NCT02085551?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2014-03. Estimated completion is 2015-09.
What conditions does trial NCT02085551 study?
This clinical trial studies the following conditions: Peripheral Arterial Occlusion or Emboli.
What interventions are being tested in trial NCT02085551?
The interventions under investigation include: Mechanical Thrombectomy by the Indigo System (DEVICE).
Who is sponsoring clinical trial NCT02085551?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02085551 being conducted?
This trial has 5 study locations across California, Florida, Illinois, North Carolina, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02085551's enrollment target sits among peer trials
85 980th of 2000 higher than 1,018 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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