Cone Beam Computed Tomography Following Thrombectomy

NCT03869567 | Unknown

• 1 other identifier: PI2018_843_0027
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral haemorrhages following reperfusion treatments involve not only rupture of the blood-brain barrier, but also direct damage to vessels related to the equipment used and secondary toxicity to thrombolytics. The rupture of the blood-brain barrier which results from ischemia / reperfusion is responsible for stagnation of the contrast product on the exams performed after thrombectomy. It is difficult to distinguish hyperdensities related to the stagnation of contrast product and Hemorrhage on a conventional scanner. The reference imaging is the double energy scanner performed at the thrombectomy outlet. But no study directly compared the results of the flat panel with the cone beam CT performed in immediate post-thrombectomy. The investigators propose a direct comparison of the cone beam CT with the dual energy CT performed at the exit of thrombectomy.

Conditions

Stroke; Hemorrhage

Keywords

thrombectomy; flat panel Computed tomography; cone beam computed tomography; hemorrhage; stroke; dual energy computed tomography

Outcome Measures

Primary Outcomes (1)

• Hemorrhage presence

  hemorrhage presence or not is determined with cone beam and scanner images

  up to two days

Secondary Outcomes (2)

• Number of patients with hemorrhagic transformation

  24 hours from symptom onset

• Health deterioration

  24 hours from symptom onset

Study Arms (1)

Cone beam CT

EXPERIMENTAL

A cone beam CT wll be performed just after thrombectomy on patients with acute ischemic stroke

Device: cone beam CT

Interventions

cone beam CT DEVICE

Just after thrombectomy, a cone beam CT will be done, while patient is on angiography table, in order to determine if hemorrhage image is due to contrast accumulation or blood-brain barrier disruption.

Cone beam CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients with cerebral thrombectomy
• Adults
• Patients able to express consent
• Signed written informed consent form
• Covered by national health insurance

You may not qualify if:

• minors
• pregnancy or beast feeding
• patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
• obstruction to participate
• non covered by national health insurance

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Conditions

Stroke; Hemorrhage

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• Cyril Chivot, Dr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 11, 2019
• Study Start: February 11, 2019
• Primary Completion: August 11, 2020
• Study Completion: June 25, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)