NCT04886687

ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Thrombectomy
• Stroke
• Ischemic

Interventions

Type	Name	Description
PROCEDURE	mechanical thrombectomy	mechanical thrombectomy

Timeline

• Start date: 2021-04-13
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-05-14
• Last updated: 2021-05-18

Locations

1 site across 1 country: Spain