BELgian CT-perFUSion Study to Select Acute Stroke Patients for Thrombectomy

NCT05685043 | Withdrawn DMC FDA Device

• 1 other identifier: BC-11282
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test whether perfusion CT can be used as a selection tool in stroke patients with a major anterior circulation occlusion, to exclude patients from thrombectomy because of a predicted non-beneficial outcome, when treated within 6 hours of symptom onset. Researchers will compare the experimental group, where mechanical thrombectomy is only performed when prespecified perfusion CT criteria are fulfilled, with the standard of care treatment group, where all patients will receive mechanical thrombectomy, to see if functional independence at 90 days is non-inferior.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic

Keywords

thrombectomy; perfusion; anterior circulation; patient selection; endovascular therapy

Outcome Measures

Primary Outcomes (1)

• Functional independence

  Functional independence at 90 days, defined as a modified Rankin scale (mRS) score of 0 to 2. The mRS is the most comprehensive and widely used post stroke disability scale \[0 (no symptoms) - 6 (death)\].

  90 days

Secondary Outcomes (3)

• Early therapeutic response

  hospital day 5-7 or at discharge (if before day 5)

• Health-related quality of life

  90 days

• Infarct evaluation

  24 hours (-6 hours / + 24 hours)

Other Outcomes (2)

• Mortality

  90 days

• Intracranial bleeding

  90 days

Study Arms (2)

best medical treatment and mechanical thrombectomy based on perfusion CT criteria

EXPERIMENTAL

In the experimental treatment group, mechanical thrombectomy is only performed when prespecified perfusion CT criteria are fulfilled. If not, the patient will only receive best medical treatment (intravenous fibrinolysis if applicable).

Device: perfusion CT

best medical treatment and mechanical thrombectomy

NO INTERVENTION

All patients in the active control arm will receive the combination of best medical treatment (intravenous fibrinolysis if applicable) and mechanical thrombectomy, regardless of the results from the perfusion CT scan. This is the current standard of care for stroke patients arriving in hospital within 6 hours after onset.

Interventions

perfusion CT DEVICE

Patients are selected for thrombectomy based on perfusion CT criteria. When the results from the perfusion CT scan (analyzed by RAPID software) indicate a core infarct volume exceeding 70 ml in patients \< 80 years or 55 ml in patients \> 80 years, then treatment is limited to best medical treatment (intravenous fibrinolysis if applicable) and no mechanical thrombectomy will be performed. This is the current standard of care for patients treated more than 6 hour after onset.

Also known as: RAPID software

best medical treatment and mechanical thrombectomy based on perfusion CT criteria

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major vessel occlusion of the anterior cerebral circulation (internal carotid artery tip, middle cerebral artery or both) on CTA
• Randomised within 6h of symptom onset
• Perfusion CT scan
• ASPECTS ≥ 5
• Age ≥18 years and ≤90 years
• Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving consent on the subject's behalf (e.g. parent or guardian of a child under 16 years of age) within 3 days after treatment.

You may not qualify if:

• Occlusion of a peripheral arterial segment (M3), anterior cerebral artery or posterior circulation
• Evidence of intracranial hemorrhage on initial CT scan
• Bad functional condition before stroke (mRS \>2)

Sponsors & Collaborators

• University Hospital, Ghent: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luc Defreyne, Prof.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The performing interventional radiologist will be blinded for the result of the perfusion CT scan, except for the information where the occlusion of the major vessel is located. The assessor of the mRS score at 90 days (primary outcome) will be blinded for the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 13, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09