N/A
Completed N=202
Solitaire FR Thrombectomy for Acute Revascularisation
Stroke, Acute
Source: ClinicalTrials.gov NCT01327989 ↗
Enrolled (actual)
202
Serious AEs
29.2%
Results posted
Jan 2017
Primary outcomePrimary: Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. — 84.2 percentage of particpants
Summary
The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. |
84.2 | — |
| PRIMARY Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). |
7.4 | — |
| SECONDARY Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram |
29 | — |
| SECONDARY Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram |
37.2 | — |
| SECONDARY Good Neurological Condition |
88.2 | — |
| SECONDARY Rate of Morbidity |
8.4 | — |
| SECONDARY Rate of Mortality |
6.9 | — |
| SECONDARY Incidence of Symptomatic Intracranial Hemorrhage |
1.5 | — |
| SECONDARY Immediate Flow Reperfusion |
11.6 | — |
Eligibility Criteria
Inclusion Criteria
- Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
- Age ≥ 18 and 30 or coma
- Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
- Use of warfarin anticoagulation with International Normalised Ratio (INR) > 3.0
- Platelet count < 30,000
- Glucose < 400 mg/dL
- Previous stroke within 30 days
- Time of symptom onset unknown
- Seizure at the onset of stroke
- Myocardial infarction or infection (sepsis or endocarditis)
- Arterial tortuosity that would prevent the device from reaching the target vessel
- Known hypersensitivity to nickel-titanium
Imaging Exclusion Criteria:
- Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
- Stenosis proximal to thrombus site that may preclude safe recovery of the device
- Brain computed tomography (CT) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm
- Early ischemic changes greater than 1/3 of the middle cerebral artery (MCA) territory or according to brain computed tomography (CT) Alberta Stroke Program Early CT (ASPECT) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (MR DWI) ASPECT score <5
Data sourced from ClinicalTrials.gov (NCT01327989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.