Ischemic StrokePhase 2PRIISMNCT00810095

Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study

A Phase 2 study testing MindFrame System in people with Ischemic Stroke, run by MindFrame, Inc. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Ischemic Stroke
What is being tested?: MindFrame System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteGermany
Study dates: Mar 2009to Apr 2011
Phase: Phase 2
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 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

NIHSS 6 to 30 within 6 hours of symptom onset
Pre-stroke Modified Rankin Score ≤ 2
Large Vessel Occlusion
Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
Patients must meet at least one of the following criteria:
Eligible for Intravenous rt-PA
Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset
Patient presents within 6 hours of symptom onset

Who cannot join

Pregnancy
Glucose <50mg/dL
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
Patient has baseline platelets < 30,000
Evidence of rapidly improving neurological signs of stroke at time of enrollment

Show all 14Show fewer

Coma
Pre-existing neurological or psychiatric disease that could confound the study results
Known severe allergy to contrast media or nitinol
Patient has severe sustained hypertension
CT/MRI scan reveals significant mass effect with midline shift
Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.
Patient's anticipated life expectancy is less than 3 months
Participation in another clinical investigation that could confound the evaluation of the study device

Trial locations and contacts

1 site in 1 country.

Germany1 site

University of Heidelberg
Heidelberg

Other trials in Germany

About this study

Official title: A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke

Read the detailed description

The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Conditions: Ischemic Stroke
Being tested: MindFrame System
Keywords: Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Penumbra, Functional Outcome, Aphasia, Hemiplegia, Left sided weakness, Right Sided weakness
Medical subject headings: Ischemic Stroke, Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Aphasia, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MindFrame SystemDevice
Also called IRIIS System, Clot, Thrombus, Mechanical Thrombectomy
Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke

Study groups in NCT00810095
Study group	Role	What they receive
Treatment Arm	Experimental	Not described Receives: Device: MindFrame System

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Measured: Immediately postprocedure
Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.
TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:
TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Measured: Immediately postprocedure
Clinical Success
Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.
Measured: 90 days postprocedure

Secondary outcomes (1)

Number of Device-related Serious Adverse Events
Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.
Measured: Treatment to 90 days postprocedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Apr 2011

First posted17 Dec 2008 (estimated)
Study startMar 2009
Primary completionApr 2011
Study completionApr 2011

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 Ischemic StrokeStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00810095
Sponsor's protocol ID: EU-PRIISM-01
Acronym: PRIISM
Status last verified: Jun 2012
First submitted: 15 Dec 2008
Last updated: 26 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Improving Visual Field Deficits With Noninvasive Brain Stimulation
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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Trial to Evaluate the MindFrame System in the Recanalization of Occluded Vessels in Patients Experiencing an Ischemic Stroke
ClinicalTrials.gov ID: NCT00810095
Acronym / sponsor ID: PRIISM / EU-PRIISM-01
Conditions: Ischemic Stroke
Keywords: Cerebral Infarction, Stroke, Vascular Diseases, Central Nervous System Diseases, Penumbra, Functional Outcome, Aphasia, Hemiplegia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: MindFrame, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 17 Dec 2008 (estimated)
Results: Posted 26 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Arm	Experimental	Device: MindFrame System

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

NIHSS 6 to 30 within 6 hours of symptom onset
Pre-stroke Modified Rankin Score ≤ 2
Large Vessel Occlusion
Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
Patients must meet at least one of the following criteria:

Key exclusion criteria (14 listed)

Pregnancy
Glucose <50mg/dL
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
Patient has baseline platelets < 30,000

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
MindFrame SystemAlso: IRIIS System, Clot, Thrombus, Mechanical ThrombectomyThrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke	Device	Treatment Arm

Primary outcome

Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.
Time frame: Immediately postprocedure
TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.
Time frame: Immediately postprocedure
TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow
Clinical Success
Time frame: 90 days postprocedure
Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.

1 secondary outcome

Number of Device-related Serious Adverse Events
Time frame: Treatment to 90 days postprocedure

Results and safety

Results posted to the registry on 26 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MindFrame System Treatment Group	40	40

Primary outcome: Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.

Time frame: Immediately postprocedure. Number. Unit: percentage of participants

Measure	Treatment Group n = 40
Value	75

Population analysed: All participants treated with the Test System

Primary outcome: Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.

Time frame: Immediately postprocedure. Number. Unit: percentage of participants

Measure	Treatment Group n = 40
Value	82.5

Population analysed: Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.

Primary outcome: Clinical Success

Time frame: 90 days postprocedure. Number. Unit: percentage of participants

Measure	Treatment Group n = 40
Value	47.5

Population analysed: Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events up to and including the 90-day follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	14 of 40 (35%)	12 of 40 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

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.

Martin Bendszus, MD, PhD principal investigator

Heidelberg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MindFrame System in people with Ischemic Stroke, run by MindFrame, Inc. at 1 site in Germany.

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 8 inclusion and 14 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 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2012). 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?

Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. (time frame: Immediately postprocedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00810095.

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 26 Jul 2012.