Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

Completed · Not applicable

Conditions studied: Peripheral Arterial Occlusion or Emboli

In brief

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.

Key facts

Study ID

NCT02085551

Run by

Penumbra Inc.

People needed

85

Starts

2014-03-01

Expected to finish

2015-09-01

Last updated by the study team

2020-06-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participation in another clinical investigation that may confound the results of the study.

Where it is running

• Tri-City Medical Center — San Diego, California, United States
• Baptist Health South Florida — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Sanford Medical Center — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.