N/A
N=85
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
Peripheral Arterial Occlusion or Emboli
Bottom Line
View on ClinicalTrials.gov: NCT02085551 ↗Enrolled (actual)
85
Serious AEs
17.7%
Results posted
Jun 2020
Primary outcome: Primary: Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores — 74 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mechanical Thrombectomy by the Indigo System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores |
74 | — |
| PRIMARY Procedural Serious Adverse Events |
5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02085551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.