Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2014 |
| End Date: | December 2015 |
| Contact: | Jeff Wayland, BS |
| Email: | jwayland@penumbrainc.com |
| Phone: | 510-995-2141 |
The Prism Trial: A Retrospective Case Review of Technical Success Using 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, 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.
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.
Inclusion Criteria:
- Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior
to treatment.
- Treatment with components of the Penumbra and/or Indigo System.
Exclusion Criteria:
- Participation in another clinical investigation that may confound the results of the
study.
We found this trial at
5
sites
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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