Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00334061 | Study to Assess the Safety and Effectiveness of the Penumbra System | PHASE2 | COMPLETED | 125 | — | — | Jun 1, 2006 | Nov 1, 2007 | Sep 18, 2019 | 1 | United States |
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.
| Name | Type | Description |
|---|---|---|
| Penumbra System | DEVICE | - |
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 st...