COmparing CeNters ThRombectomy Aspiration STentretriever

Acute Stroke Clinical Trial

— CONTRAST  

Official title:

COmparing CeNters ThRombectomy Aspiration STentretriever

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03412851
• Other study ID #: CO-18-V1.0
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2020
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: Alejandro González, MD, PhD
• Phone: +34 696646686
• Email: ggjandro[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• A Direct Aspiration First Pass Technique
Distal aspiration technique
• Stentriever Thrombectomy
Thrombectomy with stent retriever

Locations

Country	Name	City	State
Spain	Hospital Universitario de Cruces	Bilbao
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Insular de Gran Canaria	Las Palmas De Gran Canaria
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario de Donostia	San Sebastián
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clínico Universitario	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	90 days
Secondary	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.	First 14 days
Secondary	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.	Up to 24 hours after endovascular reperfusion