N/A
N=196
Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01657461 ↗Enrolled (actual)
196
Serious AEs
33.3%
Results posted
May 2017
Primary outcome: Primary: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). — 17; 8; 25; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) (Drug); Solitaire revascularization device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). |
17; 8; 25; 10; 17; 15 | — |
| SECONDARY Death Due to Any Cause at 90 Days |
9; 12 | — |
| SECONDARY Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days |
59; 33 | — |
| SECONDARY Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization |
-8.5; -3.9 | — |
| SECONDARY Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization |
60.2; 65.9 | — |
| SECONDARY Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization |
81; 61.9 | — |
| SECONDARY Arterial Revascularization Measured by TICI 2b or 3 Following Device Use |
73 | — |
| SECONDARY Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage |
0.46 | — |
Summary
The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone
Eligibility Criteria
Inclusion Criteria
- Age 18 - 80
- Clinical signs consistent with acute ischemic stroke
- Prestroke Modified Rankin Score ≤ 1
- NIHSS ≥ 8 and 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate [GFR] 100 cc of tissue) on presentation.
- Baseline non-contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) < 6.
- CT or MRI evidence of a basilar artery (BA) occlusion or posterior cerebral artery (PCA) occlusion.
- CTA or MRA evidence of carotid dissection or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy)
- Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc).
Data sourced from ClinicalTrials.gov (NCT01657461). 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.