ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques

Stroke Clinical Trial

— ROSSETTI  

Official title:

ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886687
• Other study ID #: Rossetti
• Status: Recruiting
• Start date: April 13, 2021
• Est. completion date: May 2023

Study information

• Verified date: May 2021
• Source: Hospital Clinic of Barcelona
• Contact: Jordi B Blasco Andaluz, MD, PhD
• Phone: +34607586810
• Email: 30018jba[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic
• Stroke
• Thrombectomy

Intervention

Procedure:
• mechanical thrombectomy
mechanical thrombectomy

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona	Catalunya

Sponsors (14)

Lead Sponsor

Collaborator

Hospital Clinic of Barcelona

Germans Trias i Pujol Hospital, Hospital Clinico Universitario de Santiago, Hospital de Cruces, Hospital General Universitario de Alicante, Hospital San Carlos, Madrid, Hospital Universitari de Bellvitge, Hospital Universitario Central de Asturias, Hospital Universitario Insular Gran Canaria, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Arrixaca, University Hospital of Girona Dr.Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

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