Back to resultsCase Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery (PRISM)
Primary Purpose
Peripheral Arterial Occlusion or Emboli
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mechanical Thrombectomy by the Indigo System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusion or Emboli focused on measuring peripheral arterial occlusion, visceral emboli, limb ischemia, adverse events, Indigo System, aspiration, mechanical thrombectomy
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.
Sites / Locations
- Tri-City Medical Center
- Baptist Health South Florida
- Rush University Medical Center
- Carolinas Medical Center
- Sanford Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mechanical thrombectomy by the Indigo System
Arm Description
Outcomes
Primary Outcome Measures
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores
Proportion of patients with a post-procedure TIMI score of 2 to 3.
Procedural Serious Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02085551
Brief Title
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
Acronym
PRISM
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 Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusion or Emboli
Keywords
peripheral arterial occlusion, visceral emboli, limb ischemia, adverse events, Indigo System, aspiration, mechanical thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mechanical thrombectomy by the Indigo System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mechanical Thrombectomy by the Indigo System
Primary Outcome Measure Information:
Title
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores
Description
Proportion of patients with a post-procedure TIMI score of 2 to 3.
Time Frame
Immediate post-procedure
Title
Procedural Serious Adverse Events
Time Frame
During the procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Saxon, MD
Organizational Affiliation
Tri-City Medical Center, San Diego, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corey Teigen, MD
Organizational Affiliation
Sanford Medical Center Fargo, ND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-City Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Sanford Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
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