Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Last updated: October 21, 2021
Sponsor: Nottingham University Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Neurologic Disorders

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05020795
21DI004
  • Ages > 18
  • All Genders

Study Summary

Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. Retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. However, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years
  • Acute ischemic stroke presenting with a neurological deficit of (NIHSS ≥2)
  • Intracranial arterial occlusion of the distal internal carotid artery or middlecerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as:computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), ordigital subtraction angiography (DSA).
  • ASPECTS score of >4 or by locally accepted ischaemic core/penumbra mismatch usingcomputed tomography perfusion or magnetic resonance (CTP or MR) imaging.
  • modified Rankin Scale, mRS<3
  • Intention to treat with aspiration only or combination technique of stent-retriever +aspiration in the first pass attempt during endovascular thrombectomy

Exclusion

Exclusion Criteria:

  • Severe stenosis (>90%), or tandem occlusion of the ipsilateral extracranial internalcarotid artery.
  • Previously deployed stents in the ipsilateral internal carotid artery.
  • Dissections of the ipsilateral internal carotid artery.
  • Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitorfrom overseas).
  • Subject participating in a study involving an investigational drug or device thatwould impact this study.

Study Design

Total Participants: 124
Study Start date:
October 07, 2021
Estimated Completion Date:
December 01, 2023

Connect with a study center

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.