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

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ClinicalTrials.gov Identifier: NCT02085551
Recruitment Status : Unknown
Verified September 2016 by Penumbra Inc..
Recruitment status was:  Recruiting
First Posted : March 13, 2014
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusion or Emboli Device: Mechanical Thrombectomy by the Indigo System Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
Study Start Date : March 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mechanical thrombectomy by the Indigo System Device: Mechanical Thrombectomy by the Indigo System



Primary Outcome Measures :
  1. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores [ Time Frame: Immediate post-procedure ]
  2. Procedural serious adverse events [ Time Frame: During the procedure ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085551


Contacts
Contact: Jeff Wayland, BS 510-995-2141 jwayland@penumbrainc.com
Contact: Siu P Sit, PhD 510 748 3200 siupo.sit@penumbrainc.com

Locations
United States, California
Tri-City Medical Center Recruiting
San Diego, California, United States, 92123
Contact: Richard Saxon, MD    760-940-4055    rsaxon5@gmail.com   
Contact: Lauurie Stewart    760-940-7166    laurie.stewart@sandiegoimaging.com   
Principal Investigator: Richard Saxon, MD         
United States, Florida
Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: James Benenati, MD       jamesb@baptisthealth.net   
Principal Investigator: James Benenati, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Bulent Arslan       BULENT_ARSLAN@rush.edu   
Principal Investigator: Bulent Arslan, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Frank Arko, MD       farkomd@gmail.com   
Principal Investigator: Frank Arko, MD         
United States, North Dakota
Sanford Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Amber Leach    701-234-5899    amber.leach@sanfordhealth.org   
Contact: Jennifer Wurgler    701-234-6233    jennifer.wurgler@sanfordhealth.org   
Principal Investigator: Corey Teigen, MD         
Sponsors and Collaborators
Penumbra Inc.
Investigators
Principal Investigator: Richard Saxon, MD Tri-City Medical Center, San Diego, CA
Principal Investigator: Corey Teigen, MD Sanford Medical Center Fargo, ND

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT02085551     History of Changes
Other Study ID Numbers: CLP 7051
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Keywords provided by Penumbra Inc.:
peripheral arterial occlusion
visceral emboli
limb ischemia
adverse events
Indigo System
aspiration
mechanical thrombectomy

Additional relevant MeSH terms:
Embolism
Arterial Occlusive Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases