NCT04886687

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

April 22, 2021

Last Update Submit

May 14, 2021

Conditions

ThrombectomyStrokeIschemic

Keywords

mechanical thrombectomystroke

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

mechanical thrombectomyPROCEDURE

mechanical thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

StrokeIschemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jordi Blasco Andaluz, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi B Blasco Andaluz, MD, PhD

CONTACT

+3460758681030018jba@gmail.com

Luis San Roman Manzanera, MD, PhD

CONTACT

+34932275400lroman1@clinic.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 14, 2021

Study Start

April 13, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)