ThrombectomyROSSETTINCT04886687
ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques
An observational study of Thrombectomy and Stroke, run by Hospital Clinic of Barcelona at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombectomy, Stroke, Ischemic
- What is being tested?
- mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2021to May 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke due to large vessel occlusion of the anterior circulation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic of Barcelona
Barcelona, Catalonia, 08036
Jordi Blasco, MD, 34 607586810, 30018jba@gmail.com
Jordi Blasco, MD
About this study
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
Read the 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
- Being tested
- mechanical thrombectomy
- Keywords
- mechanical thrombectomy, stroke
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical thrombectomyProcedure or surgery
mechanical thrombectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
modified Rankin Score, 0 to 6, higher scores mean a worse outcome
Measured: 3 months after thrombectomy
Technical Outcome
Thrombolysis in Cerebral Infarction Scale, 0 to 3, higher scores mean a better outcome
Measured: 1 day, revascularization grade will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start13 Apr 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombectomyStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital Universitari de Bellvitge, University Hospital of Girona Dr. Josep Trueta, Hospital de Cruces, Hospital Universitario Central de Asturias, Hospital Clinico Universitario de Santiago, Hospital San Carlos, Madrid, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Insular Gran Canaria, Hospital General Universitario de Alicante, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Sponsor
- Investigators
- Jordi Blasco Andaluz, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886687
- Sponsor's protocol ID
- Rossetti
- Acronym
- ROSSETTI
- Status last verified
- May 2021
- First submitted
- 22 Apr 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques
- ClinicalTrials.gov ID
- NCT04886687
- Acronym / sponsor ID
- ROSSETTI / Rossetti
- Conditions
- Thrombectomy, Stroke, Ischemic
- Keywords
- mechanical thrombectomy, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital Universitari de Bellvitge, University Hospital of Girona Dr. Josep Trueta, Hospital de Cruces, Hospital Universitario Central de Asturias, Hospital Clinico Universitario de Santiago, Hospital San Carlos, Madrid, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Insular Gran Canaria, Hospital General Universitario de Alicante, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario Virgen de la Arrixaca
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke due to large vessel occlusion of the anterior circulation
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical thrombectomymechanical thrombectomy | Procedure or surgery | – |
Primary outcome
Clinical Outcome
Time frame: 3 months after thrombectomy
modified Rankin Score, 0 to 6, higher scores mean a worse outcome
Technical Outcome
Time frame: 1 day, revascularization grade will be assessed
Thrombolysis in Cerebral Infarction Scale, 0 to 3, higher scores mean a better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Blasco Andaluz, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombectomy and Stroke, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi B Blasco Andaluz, MD, PhD (+34607586810, 30018jba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome (time frame: 3 months after thrombectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.