CompletedNot Applicable

Solitaire FR Thrombectomy for Acute Revascularisation

Switzerland202 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range18 Years – 84 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
✓. Age ≥ 18 and \< 85
✓. Clinical signs consistent with acute ischemic stroke
✓. Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal Carotid Artery (ICA) terminal)
✓. Presentation within 8 hours of stroke onset according to local stroke protocol
✓. If stroke presentation within 4.5 hours, one of these conditions can be met:
✓. Subject is willing to conduct follow-up visits.
✓. National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30

Exclusion criteria

✕. Females who are pregnant or lactating
✕. Known serious sensitivity to radiographic contrast agents
✕. Neurological signs that are rapidly improving prior to or at time of treatment
✕. Current participation in another investigational drug or device study
✕. Life expectancy of less than 90 days
✕. National Institutes of Health Stroke Scale (NIHSS) \> 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

What they're measuring

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.

Timeframe: Immediately post procedure

Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).

Timeframe: 90 Days

Trial details

NCT IDNCT01327989

SponsorMedtronic Neurovascular Clinical Affairs

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-10

Results submitted2016-10-12

View on ClinicalTrials.gov More Stroke, Acute trials