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Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
NCT02085551 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02085551
The ClinicalTrials.gov registry entry for NCT02085551 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02085551 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02085551?
The interventions under investigation include: Mechanical Thrombectomy by the Indigo System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02085551?
This trial is sponsored by Penumbra, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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