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MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)

MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02668627
Enrollment
120
Registered
2016-01-29
Start date
2013-12-31
Completion date
2018-05-31
Last updated
2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Collateral status, Endovascular treatment

Brief summary

Based on the results of recent randomized controlled trials, current international guidelines recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour time window. In particular, treatment response to endovascular therapy may be greatly influenced by pretreatment collateral status. The aim of this study is to evaluate whether MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is feasible and can predict the response to endovascular treatment in a wide range of patients with acute ischemic stroke .

Interventions

PROCEDUREEndovascular treatment

Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Acute ischemic stroke * Age 20 years and older * Disabling stroke defined as a baseline NIHSS \> 5 at the time of arrival * Onset (last-seen-well) time to endovascular treatment time \< 12 hours * Confirmed symptomatic intracranial occlusion, based on CT or MR angiography, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs) * Signed informed consent or appropriate signed deferral of consent where approved

Exclusion criteria

* Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion. * Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic * Unable to undergo MRI (contraindicated or poor cooperation) * Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient * Pregnant females as determined by positive urine hCG test or lactating females

Design outcomes

Primary

MeasureTime frameDescription
90-days functional outcome90-days90-days modified Rankin Scale ≤ 2

Secondary

MeasureTime frameDescription
Early neurologic improvement24 hoursAn 8-point or more improvement on the NIH score when comparing the baseline score or a NIHSS score of 0-1, at 24 hours.
Symptomatic hemorrhagic transformationDuring initial admissionOccurrence of an increase in the National Institutes of Health Stroke Scale (NIHSS) score of 4 or more points in the setting of local or remote parenchymal hematoma.
Successful recanalizationwithin 24 hours of symptom onsetDefined as modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b

Countries

South Korea

Contacts

Primary ContactJong-Won Chung, MD
neurocjw@gmail.com82234103599
Backup ContactYun Jeong Lim, RN
smcyunjeong@naver.com82221489697

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026