ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques

• Conditions: Stroke; Thrombectomy; Ischemic

• Registration Number: NCT04886687
• Lead Sponsor: Hospital Clinic of Barcelona

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

Study Timeline

• Study Start: 2021-04-13
• Study First Submitted: 2021-04-22
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-18
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Catalunya, Spain