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

MindFrame

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Device: MindFrame System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810095

EU-PRIISM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. NIHSS 6 to 30 within 6 hours of symptom onset

2. Pre-stroke Modified Rankin Score ≤ 2

3. Large Vessel Occlusion

4. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.

5. 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

1. Pregnancy
2. Glucose <50mg/dL
3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
5. Patient has baseline platelets < 30,000
6. Evidence of rapidly improving neurological signs of stroke at time of enrollment
7. Coma
8. Pre-existing neurological or psychiatric disease that could confound the study results
9. Known severe allergy to contrast media or nitinol
10. Patient has severe sustained hypertension
11. CT/MRI scan reveals significant mass effect with midline shift
12. Patient's angiogram shows an arterial stenosis >50% proximal to the embolus.
13. Patient's anticipated life expectancy is less than 3 months
14. Participation in another clinical investigation that could confound the evaluation of the study device

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment Arm

Experimental group

Treatment:

Device: MindFrame System