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

Ischemic Stroke Clinical Trial

— PRIISM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810095
• Other study ID #: EU-PRIISM-01
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2008
• Last updated: June 19, 2012
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: MindFrame, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionPoland: Ethics CommitteeSweden: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• MindFrame System
Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
MindFrame, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	Immediately postprocedure	No
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.	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	Immediately postprocedure	No
Primary	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.	90 days postprocedure	No
Secondary	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.	Treatment to 90 days postprocedure	Yes