Assess the Penumbra System in the Treatment of Acute Stroke

Ischemic Stroke Clinical Trial

— THERAPY  

Official title:

The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429350
• Other study ID #: CLP 4338
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: October 2016

Study information

• Verified date: September 2020
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Description:

Current therapies for acute stroke are limited to the intravenous administration of a intravenous (IV) recombinant human tissue plasminogen activator (rtPA) for thrombolysis of the affected cerebral arteries within 3-4.5 hours from symptom onset, and the use of intra-arterial (IA) endovascular mechanical clot retrieval devices within 8 hours from ictus, all of which have limitations as mono therapies. For example, IV rtPA may not be very efficacious in large vessel occlusion and the long term effects of mechanical thrombectomy devices on patient functional outcome is unknown. This is a randomized, concurrent controlled study to assess the safety and effectiveness of the Penumbra System as adjunctive therapy to IV rtPA in the acute intervention of acute ischemic stroke. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large clot burden (clot length > 8mm) in the anterior circulation will be assigned to either IV rtPA therapy alone (0.9mg/kg to a maximum of 90mg) or a combined IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and intra-arterial (IA) adjunctive treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. From 18 to 85 years of age

2. Present with symptoms consistent with an acute ischemic stroke and eligible for IV rtPA therapy (patients presenting 3-4.5 hrs from symptom onset are not eligible if they are >80 yrs of age, have a history of stroke and diabetes, anticoagulant use (even if INR is <1.7) and have a NIHSS score >25

3. Evidence of a large vessel occlusion in the anterior circulation with a clot length of 8mm or longer

4. NIH Stroke Scale (NIHSS) score 8 or greater or aphasic at presentation

5. Signed informed consent

Exclusion Criteria:

1. History of stroke in the past 3 months.

2. Females who are pregnant

3. Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or greater

4. Known severe allergy to contrast media

5. Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)

6. CT evidence of the following conditions at randomization:

• Significant mass effect with midline shift

• Any acute ischemic changes in >1/3 of the affected middle cerebral artery territory

• Evidence of intracranial hemorrhage

7. Angiographic evidence of tantem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion

8. Angiographic evidence of preexisting arterial injury

9. Rapidly improving neurological status prior to randomization

10. Bilateral stroke

11. Intracranial tumors

12. Known history of cerebral aneurysm or arteriovenous malfunction

13. Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7

14. Baseline platelets <50,000

15. Use of IV heparin in the past 48 hours with PPT >1.5 times the normalized ratio

16. Pre-treatment glucose <50mg/dL or >300mg/dL

17. Life expectancy less than 90 days prior to stroke onset

18. Participation in another clinical investigation that could confound the evaluation of the study device

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
0.9mg/kg to a maximum of 90mg

Device:
• Penumbra System
The Penumbra System is an aspiration based mechanical thrombectomy device

Locations

Country	Name	City	State
United States	Neurosurgery, Rush University Medical Center	Chicago	Illinois
United States	Endovascular Surgical Neuroradiology, Swedish Medical Center	Denver	Colorado
United States	Department of Neurological Surgery	Gainesville	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good Functional Outcome as Defined by a Modified Rankin Score of 0-2	The assessor is blinded to patient treatment assignment.	90 days
Primary	Incidence of All Serious Adverse Events	A Serious Adverse Event is defined as an event that: Led to death; Led to a serious deterioration in the health of the patient that: Resulted in life-threatening illness or injury; Resulted in permanent impairment of a body structure or a body function; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function; Led to fetal distress, fetal death or a congenital abnormality or birth defect	90 days
Secondary	Good Clinical Outcome	Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIH stroke scale score at Discharge, a NIH stroke scale score of 0-1 at Discharge; or a 30-day modified Rankin scale score of 0-2	30 days
Secondary	Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage	A symptomatic intracranial hemorrhage is defined as 24 hour CT evidence of an ECASS defined ICH and a 4-point or more worsening of the NIH Stroke Scale score	90 days