Assess the Penumbra System in the Treatment of Acute Stroke "THERAPY"

Active, not recruiting

Phase 4 Results N/A

Update History

29 Sep '16
The eligibility criteria were updated.
New
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
Old
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
18 Jun '15
The eligibility criteria were updated.
New
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
Old
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 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 - Large infarct region >1/3 of the middle cerebral artery territory - Evidence of intracranial hemorrhage 7. Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal 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. Baseline 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
11 Nov '14
A location was updated in Gainesville.
New
The overall status was removed for Department of Neurological Surgery.
A location was updated in Denver.
New
The overall status was removed for Endovascular Surgical Neuroradiology, Swedish Medical Center.
A location was updated in Milwaukee.
New
The overall status was removed for Medical College of Wisconsin.
A location was updated in Chicago.
New
The overall status was removed for Neurosurgery, Rush University Medical Center.
22 Feb '14
A location was updated in Gainesville.
New
The overall status was removed for Department of Neurological Surgery.
A location was updated in Chicago.
New
The overall status was removed for Neurosurgery, Rush University Medical Center.
A location was updated in Milwaukee.
New
The overall status was removed for Medical College of Wisconsin.
7 Apr '12
The eligibility criteria were updated.
New
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 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 - Large infarct region >1/3 of the middle cerebral artery territory - Evidence of intracranial hemorrhage 7. Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal 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. Baseline 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
Old
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 3. Evidence of a large vessel occlusion in the anterior circulation with a clot length of > 8mm 4. NIH Stroke Scale (NIHSS) score > 8 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 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 - Large infarct region >1/3 of the middle cerebral artery territory - Evidence of intracranial hemorrhage 7. Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal 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 >2.0 14. Baseline platelets <50,000 15. Use of IV heparin in the past 48 hours with PPT >1.5 times the normalized ratio 16. Baseline 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
6 Jan '12
A location was updated in Gainesville.
New
The overall status was removed for Department of Neurological Surgery.
A location was updated in Chicago.
New
The overall status was removed for Neurosurgery, Rush University Medical Center.
A location was updated in Milwaukee.
New
The overall status was removed for Medical College of Wisconsin.