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

NCT ID: NCT00810095

Last Updated: 2012-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-04-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Group Type: EXPERIMENTAL

MindFrame System

Intervention Type: DEVICE

Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke

Interventions

MindFrame System

Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke

Intervention Type: DEVICE

Other Intervention Names

IRIIS System; Clot; Thrombus; Mechanical Thrombectomy; Ischemic Stroke; Intervention; Neurovascular

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MindFrame, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Bendszus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

University of Heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

EU-PRIISM-01

Identifier Type: -

Identifier Source: org_study_id