N/A
Completed N=85
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
Peripheral Arterial Occlusion or Emboli
Source: ClinicalTrials.gov NCT02085551 ↗
Enrolled (actual)
85
Serious AEs
17.7%
Results posted
Jun 2020
Primary outcomePrimary: Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores — 74 Participants
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.
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 | — |
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. Informational only — not medical advice.