Stroke
Conditions
Keywords
Penumbra, Ischemic, Stroke, Intervention, Neurovascular, Thrombus, Embolectomy, Ischemic stroke
Brief summary
This clinical evaluation is a prospective, single-arm, multi-center trial. The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
Detailed description
Purpose: The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.
Interventions
DEVICEPenumbra System
Sponsors
Penumbra Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Clinical signs consistent with acute ischemic stroke * 18 to 79 years of age * Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 8 * TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System * Signed informed consent * Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.
Exclusion criteria
* Evidence of rapidly improving neurological signs of stroke at time of enrollment * NIHSS \> 30 or coma * Females who are pregnant * Vessel tortuosity too difficult to allow endovascular access * Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) \> 3.0 * Partial thromboplastin time (PTT) greater than 2 times the lab normal * Admission platelets \< 30,000 * Pre-existing neurological or psychiatric disease that could confound the study results * Known severe allergy to contrast media * Uncontrolled hypertension * Computed tomography (CT) evidence of significant mass effect with a midline shift * CT reveals evidence of large hypodensity region \> 1/3 of the middle cerebral artery territory * CT reveals evidence of intracranial hemorrhage * CT reveals significant mass effect with midline shift * Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal * Angiographic evidence of preexisting arterial injury * Life expectancy of less than 90 days * Participation in another clinical investigation that could confound the evaluation of the study device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Revascularization of the Occluded Target Vessel | 3-Month Post-Procedure | Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow. |
| Percentage of Participants With Device-related and Procedure-related Serious Adverse Events | 3-Month Post-Procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment | Discharge or 30-Days Post-Procedure | NIHSS is a 42 point scale to describe the neurological status of the patients: 0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death. |
| Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment | 90-Day | The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death. |
| Percentage of Participants With All Cause Mortality | 90-Days Post-Treatment | — |
| Percentage of Participants With Symptomatic Hemorrhage | 24-Hour Post-Procedure | All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage. |
Countries
United States
Participant flow
Recruitment details
From June 19, 2006 to June 5, 2007 a total of 856 patients were screened of which 125 patients were enrolled at 24 centers in Europe and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Penumbra System | 125 |
| Total | 125 |
Baseline characteristics
| Characteristic | Penumbra System |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 71 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment Europe | 49 participants |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 125 / 125 |
| serious Total, serious adverse events | 65 / 125 |
Outcome results
Primary
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
Time frame: 3-Month Post-Procedure
Population: All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra System | Percentage of Participants With Device-related and Procedure-related Serious Adverse Events | 2.4 Percentage of Participants |
Primary
Percentage of Participants With Revascularization of the Occluded Target Vessel
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
Time frame: 3-Month Post-Procedure
Population: Intention to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra System | Percentage of Participants With Revascularization of the Occluded Target Vessel | 81.2 Percentage of Participants |
Secondary
Percentage of Participants With All Cause Mortality
Time frame: 90-Days Post-Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra System | Percentage of Participants With All Cause Mortality | 32.8 Percentage of Participants |
Secondary
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment
The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.
Time frame: 90-Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra System | Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment | 25 Percentage of Participants |
Secondary
Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment
NIHSS is a 42 point scale to describe the neurological status of the patients: 0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.
Time frame: Discharge or 30-Days Post-Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra System | Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment | 41.6 Percentage of Participants |
Secondary
Percentage of Participants With Symptomatic Hemorrhage
All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.
Time frame: 24-Hour Post-Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penumbra System | Percentage of Participants With Symptomatic Hemorrhage | 11.2 Percentage of Participants |