Phase 2
Completed N=40
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study
Source: ClinicalTrials.gov NCT00810095 ↗Enrolled (actual)
40
Serious AEs
35.0%
Results posted
Jul 2012
Primary outcomePrimary: 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. — 75 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
75 | — |
| PRIMARY 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. |
82.5 | — |
| PRIMARY Clinical Success |
47.5 | — |
| SECONDARY Number of Device-related Serious Adverse Events |
2 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancy
- Glucose 3.0
- Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
- Patient has baseline platelets 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
Data sourced from ClinicalTrials.gov (NCT00810095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.