ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-13

Study Completion Date

2023-05-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Thrombectomy Stroke Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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mechanical thrombectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No