Stroke Clinical Trial
— ROSSETTIOfficial title:
ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques
NCT number | NCT04886687 |
Other study ID # | Rossetti |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 13, 2021 |
Est. completion date | May 2023 |
The ROSSETTI registry is an ongoing investigator-initiated prospective study recruiting deidentified demographic, clinical presentation, site-adjudicated angiographic, procedural, and outcome data in acute ischemic stroke (AIS) consecutive patients treated with mechanical thrombectomy (MT) across 10 Comprehensive Stroke Centers in Spain. The registry started in June 2019 and therefore incorporates the more recent device technology
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | May 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age =18 years; - confirmed large vessel occlusion in the anterior circulation (intracranial internal carotid artery, M1segment of middle cerebral artery, proximal M2 segment of middle cerebral artery - time from last seen well to treatment (TLSWT) <24 hours, - baseline National Institutes of Health Stroke Scale (NIHSS) score =2, - premorbid modified Rankin Scale (mRS) score =2. Exclusion Criteria: - No evidence vessel occlusion. - Extra and Intracranial occlusion or severe stenosis. - Low platelets (100 x 10000) or impaired function, - Contraindication of computed tomography or magnetic resonance - Allergy to iodinated contrast non treatable medically, - pregnant or breast feeding patient, - hemorrhagic stroke on computed tomography or Magnetic Resonance |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic of Barcelona | Barcelona | Catalunya |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Germans Trias i Pujol Hospital, Hospital Clinico Universitario de Santiago, Hospital de Cruces, Hospital General Universitario de Alicante, Hospital San Carlos, Madrid, Hospital Universitari de Bellvitge, Hospital Universitario Central de Asturias, Hospital Universitario Insular Gran Canaria, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Arrixaca, University Hospital of Girona Dr.Josep Trueta |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Outcome | modified Rankin Score, 0 to 6, higher scores mean a worse outcome | 3 months after thrombectomy | |
Primary | Technical Outcome | Thrombolysis in Cerebral Infarction Scale, 0 to 3, higher scores mean a better outcome | 1 day, revascularization grade will be assessed |
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