ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques (ROSSETTI)

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Thrombectomy; Ischemic
• Intervention / Treatment: Procedure: mechanical thrombectomy

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Jordi B Blasco Andaluz, MD, PhD; Phone Number: +34607586810; Email: 30018jba@gmail.com
• Study Contact Backup: Name: Luis San Roman Manzanera, MD, PhD; Phone Number: 2662 +34932275400; Email: lroman1@clinic.cat

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Recruiting
      • Hospital Clinic of Barcelona
      • Contact: Jordi Blasco, MD; Phone Number: 34 607586810; Email: 30018jba@gmail.com
      • Principal Investigator: Jordi Blasco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute ischemic stroke due to large vessel occlusion of the anterior circulation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome	modified Rankin Score, 0 to 6, higher scores mean a worse outcome	3 months after thrombectomy
Technical Outcome	Thrombolysis in Cerebral Infarction Scale, 0 to 3, higher scores mean a better outcome	1 day, revascularization grade will be assessed

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Germans Trias i Pujol Hospital; Hospital Universitario Ramon y Cajal; Hospital Universitari de Bellvitge; Hospital Universitario Virgen de la Arrixaca; Hospital Universitario Reina Sofia de Cordoba; Hospital San Carlos, Madrid; Hospital Universitario La Paz; Hospital Universitario Central de Asturias; Hospital General Universitario de Alicante; Hospital Clinico Universitario de Santiago; Hospital de Cruces; University Hospital of Girona Dr.Josep Trueta; Hospital Universitario Insular Gran Canaria
• Investigators: Principal Investigator: Jordi Blasco Andaluz, MD, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (ACTUAL): May 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: stroke; mechanical thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Rossetti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No