Clinical trial NCT04886687: ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques
Official title: ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombectomy
Stroke
Ischemic
Keywords: mechanical thrombectomy
stroke
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
name: Hospital Universitari de Bellvitge
name: University Hospital of Girona Dr.Josep Trueta
name: Hospital de Cruces
name: Hospital Universitario Central de Asturias
name: Hospital Clinico Universitario de Santiago
name: Hospital San Carlos, Madrid
name: Hospital Universitario Reina Sofia de Cordoba
name: Hospital Universitario Insular Gran Canaria
name: Hospital General Universitario de Alicante
name: Hospital Universitario La Paz
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario Virgen de la Arrixaca
First posted: 2021-05-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke due to large vessel occlusion of the anterior circulation

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Outcome
timeFrame: 3 months after thrombectomy
measure: Technical Outcome
timeFrame: 1 day, revascularization grade will be assessed
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
state: Catalunya
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jordi Blasco Andaluz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: