Peripheral Arterial Occlusion or EmboliPRISMNCT02085551
Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
A study testing Mechanical Thrombectomy by the Indigo System in people with Peripheral Arterial Occlusion or Emboli, run by Penumbra Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Occlusion or Emboli
- What is being tested?
- Mechanical Thrombectomy by the Indigo System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participation in another clinical investigation that may confound the results of the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Rush University Medical Center
Chicago, Illinois, 60612
Sanford Medical Center
Fargo, North Dakota, 58122
Baptist Health South Florida
Miami, Florida, 33176
Tri-City Medical Center
San Diego, California, 92123
About this study
Official title: The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
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.
- Conditions
- Peripheral Arterial Occlusion or Emboli
- Being tested
- Mechanical Thrombectomy by the Indigo System
- Keywords
- peripheral arterial occlusion, visceral emboli, limb ischemia, adverse events, Indigo System, aspiration, mechanical thrombectomy
- Medical subject headings
- Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Thrombectomy by the Indigo SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Mechanical thrombectomy by the Indigo System | Experimental | Not described Receives: Device: Mechanical Thrombectomy by the Indigo System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate post-procedure
Procedural Serious Adverse Events
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial Occlusion or EmboliStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Saxon, MD, Principal investigator, Tri-City Medical Center, San Diego, CACorey Teigen, MD, Principal investigator, Sanford Medical Center Fargo, ND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085551
- Sponsor's protocol ID
- CLP 7051
- Acronym
- PRISM
- Status last verified
- Jun 2020
- First submitted
- 5 Mar 2014
- Last updated
- 22 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
- ClinicalTrials.gov ID
- NCT02085551
- Acronym / sponsor ID
- PRISM / CLP 7051
- Conditions
- Peripheral Arterial Occlusion or Emboli
- Keywords
- peripheral arterial occlusion, visceral emboli, limb ischemia, adverse events, Indigo System, aspiration, mechanical thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 22 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical thrombectomy by the Indigo System | Experimental | Device: Mechanical Thrombectomy by the Indigo System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in another clinical investigation that may confound the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Thrombectomy by the Indigo System | Device | Mechanical thrombectomy by the Indigo System |
Primary outcome
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores
Time frame: Immediate post-procedure
Proportion of patients with a post-procedure TIMI score of 2 to 3.
Procedural Serious Adverse Events
Time frame: During the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Saxon, MD principal investigator
Tri-City Medical Center, San Diego, CA
Corey Teigen, MD principal investigator
Sanford Medical Center Fargo, ND
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Thrombectomy by the Indigo System in people with Peripheral Arterial Occlusion or Emboli, run by Penumbra Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores (time frame: Immediate post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.