Ischemic, Stroke, Thrombectomy
Conditions
Keywords
mechanical thrombectomy, stroke
Brief summary
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
Detailed description
The study inclusion criteria are the following: age ≥18 years; confirmed large vessel occlusion (LVO) in the anterior circulation (intracranial internal carotid artery M1, proximal M2 segments, time from last seen well to treatment (TLSWT) \<24 hours, baseline National Institutes of Health Stroke Scale (NIHSS) score ≥2, and premorbid modified Rankin Scale (mRS) score ≤2. All participating centers received institutional review board approval from their respective institutions and patients or representatives signed informed consent. The study data are collected prospectively through an online questionnaire. Type of stent-retriever , as long as European Community approved, is at the discretion of the operator. The primary clinical outcome is the rate of excellent clinical outcome, defined as mRS score 0-1 at 90 days (no or minor symptoms but no functional limitations).\[28\] The primary technical outcome is the rate of first pass effect (FPE) defined as achieving near-complete/complete revascularization \[modified Thrombolysis in Cerebral Infarction (mTICI 2c-3)\] after single-device and single-pass approach
Interventions
PROCEDUREmechanical thrombectomy
mechanical thrombectomy
Sponsors
Germans Trias i Pujol Hospital
Hospital Universitari de Bellvitge
University Hospital of Girona Dr. Josep Trueta
Hospital de Cruces
Hospital Universitario Central de Asturias
Hospital Clinico Universitario de Santiago
Hospital San Carlos, Madrid
Hospital Universitario Reina Sofia de Cordoba
Hospital Universitario Insular Gran Canaria
Hospital General Universitario de Alicante
Hospital Universitario La Paz
Hospital Universitario Ramon y Cajal
Hospital Universitario Virgen de la Arrixaca
Hospital Clinic of Barcelona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome | 3 months after thrombectomy | modified Rankin Score, 0 to 6, higher scores mean a worse outcome |
| Technical Outcome | 1 day, revascularization grade will be assessed | Thrombolysis in Cerebral Infarction Scale, 0 to 3, higher scores mean a better outcome |
Countries
Spain
Contacts
Primary ContactJordi B Blasco Andaluz, MD, PhD
Backup ContactLuis San Roman Manzanera, MD, PhD
Outcome results
None listed