Acute StrokeCONTRASTNCT03412851
COmparing CeNters ThRombectomy Aspiration STentretriever
An observational study of Acute Stroke, run by Hospitales Universitarios Virgen del Rocío at 9 sites in Spain.
Trial summary
Our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- A Direct Aspiration First Pass Technique and Stentriever Thrombectomy
- How many people
- 1,000 participants
- Where
- 9 sitesSpain
- Study dates
- 1 Apr 2018to 1 Jun 2021
- How long will I take part?
- 3 Years
- 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: Patients with acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).
Who may be able to join
- Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).
- Subjects in which the aspiration technique is used for at least the first two thrombectomy passes per occluded vessel.
- Subjects older than 18 yo.
- Subjects with a prestroke modified Rankin scale of 0-2 and presenting with an NIHSS of 2-30.
- Subjects that the operator feels may be treated with endovascular therapy
- Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better.
- Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration). In those Patients of more than 8 hours or awake stroke or of unknown onset should be individualized the treatment and must exist area of penumbra in CT perfusion
- Subjects who have consented in accordance with local Institutional Review Board requirements
Who cannot join
- Absence of large vessel occlusion on neuroimaging.
- Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction.
- Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging).
- Previously documented contrast allergy that is not amenable to medical treatment.
- Women who are pregnant or breastfeeding at time of intervention.
- Evidence of brain hemorrhage on CT and/or MRI at presenting hospital.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Not yet recruiting
Hospital Universitario de Cruces
Bilbao
Alain Luna
- Not yet recruiting
Hospital Universitario Reina Sofia
Córdoba
Fernando Delgado, MD, PhD
- Not yet recruiting
Hospital Universitario Virgen de las Nieves
Granada
Pedro Pablo Alcazar, MD, PhD
- Not yet recruiting
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria
Yeray Aguilar, MD
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Joaquin Zamarro, MD
- Not yet recruiting
Hospital Universitario Central de Asturias
Oviedo
Pedro Vega, MD
- Not yet recruiting
Hospital Universitario de Donostia
San Sebastián
Pedro Navia, MD
- Not yet recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Andrés González Mandly, MD
- Not yet recruiting
Hospital Clínico Universitario
Valladolid
Juan Arenillas, MD, PhD
About this study
Our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective study.
- Conditions
- Acute Stroke
- Being tested
- A Direct Aspiration First Pass Technique, Stentriever Thrombectomy
- Keywords
- Thrombectomy, Stentriever, ADAPT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Direct Aspiration First Pass TechniqueOther
Distal aspiration technique
Stentriever ThrombectomyOther
Thrombectomy with stent retriever
| Study group | Role | What they receive |
|---|---|---|
| A Direct Aspiration First Pass Technique | Not described Receives: Other: A Direct Aspiration First Pass Technique | |
| Stentriever Thrombectomy | Not described Receives: Other: Stentriever Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified rankin scale (mRs) at 90 days [effectiveness]
Is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Score Description: The scale runs from 0-6, running from perfect health without symptoms to death.
0 No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead [Time Frame: 90 days]
Measured: 90 days
Secondary outcomes (2)
Symptomatic intracranial bleeding [safety of the technique]
The rate of patients with intracranial hemorrhage (measured by computed tomography) with worsening of 4 points on the NIHSS scale will be evaluated.
Measured: First 14 days
Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness]
After endovascular reperfusion technique, TICI score will be evaluated in all consecutive patients. The rate of TICI 2b-3 will be recorded as a effectiveness endpoint.
Measured: Up to 24 hours after endovascular reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Apr 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro González, Hospitales Universitarios Virgen del Rocío
- Investigators
- Alejandro González, MD, PhD, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412851
- Sponsor's protocol ID
- CO-18-V1.0
- Acronym
- CONTRAST
- Status last verified
- Feb 2020
- First submitted
- 12 Jan 2018
- Last updated
- 18 Feb 2020
- 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 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparing CeNters ThRombectomy Aspiration STentretriever
- ClinicalTrials.gov ID
- NCT03412851
- Acronym / sponsor ID
- CONTRAST / CO-18-V1.0
- Conditions
- Acute Stroke
- Keywords
- Thrombectomy, Stentriever, ADAPT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 Jan 2018 (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.
Our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Direct Aspiration First Pass Technique | – | Other: A Direct Aspiration First Pass Technique |
| Stentriever Thrombectomy | – | Other: Stentriever Thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).
Key inclusion criteria (8 listed)
- Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).
- Subjects in which the aspiration technique is used for at least the first two thrombectomy passes per occluded vessel.
- Subjects older than 18 yo.
- Subjects with a prestroke modified Rankin scale of 0-2 and presenting with an NIHSS of 2-30.
- Subjects that the operator feels may be treated with endovascular therapy
Key exclusion criteria (6 listed)
- Absence of large vessel occlusion on neuroimaging.
- Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction.
- Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging).
- Previously documented contrast allergy that is not amenable to medical treatment.
- Women who are pregnant or breastfeeding at time of intervention.
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 |
|---|---|---|
| A Direct Aspiration First Pass TechniqueDistal aspiration technique | Other | A Direct Aspiration First Pass Technique |
| Stentriever ThrombectomyThrombectomy with stent retriever | Other | Stentriever Thrombectomy |
Primary outcome
modified rankin scale (mRs) at 90 days [effectiveness]
Time frame: 90 days
Is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score Description: The scale runs from 0-6, running from perfect health without symptoms to death. 0 No symptoms at all No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead [Time Frame: 90 days]
2 secondary outcomes
Symptomatic intracranial bleeding [safety of the technique]
Time frame: First 14 days
Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness]
Time frame: Up to 24 hours after endovascular reperfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- 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.
Alejandro González, MD, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Hospitales Universitarios Virgen del Rocío at 9 sites 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 8 inclusion and 6 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Alejandro González, MD, PhD (+34 696646686, ggjandro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified rankin scale (mRs) at 90 days [effectiveness] (time frame: 90 days). 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 Feb 2020.