ProFATE
Research type
Research Study
Full title
Effect of Proximal Blood Flow Arrest during Endovascular Thrombectomy
IRAS ID
300181
Contact name
Maria Koufali
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov, Pending
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary
Nowadays, we can treat acute stroke patients with ‘endovascular thrombectomy’ by removing a blood clot blocking a large brain blood vessel using:
- 1)aspiration “vacuum cleaner” and/or
- 2)stent-retrievers “platinum mesh”
During clot-retrieval, constant incoming blood flow may fragment the clot and cause a stroke elsewhere. To lower this risk, we can transiently inflate a balloon over the device. Early studies indicate that balloon inflation may improve patients’ outcomes when stent-retriever or aspiration techniques are used separately. However, when both devices are combined, there is little evidence to suggest any difference in the efficacy of using of balloon inflation. Clinical opinion remains divided. Not using a balloon inflation device may be safer for patients and can be cost-saving.We aim to test the efficacy of the balloon inflation during the procedure. We plan to recruit 124 patients with acute stroke who are eligible for endovascular thrombectomy. They will be treated at a single tertiary stroke centre using a combined technique (aspiration and stent-retriever) & randomised to with/without balloon inflation treatment. We will analyse the rate of successful vessel opening and functional independence at 90 days. Ultimately, the results will help inform current clinical practice and potentially be a catalyst for larger multicentre trials.
Summary of Results
Question Does temporary blood flow arrest during endovascular thrombectomy for anterior circulation acute ischemic stroke improve vessel recanalization rates compared to no flow arrest?
Findings
In this multicentre randomized controlled trial that included 134 participants with anterior circulation large vessel occlusion, blood flow arrest did not significantly improve the near-complete/complete vessel recanalization (expanded Thrombolysis In Cerebral Infarction score of 2c or 3) at the end of the thrombectomy procedure, compared to no flow arrest. However, a lower rate of emboli to a new vascular territory and a higher rate of complete recanalization after the first thrombectomy attempt were achieved in the blood flow arrest group compared to the non-flow arrest group.Meaning
Amongst participants presenting with anterior circulation large vessel occlusion acute ischemic stroke, temporary blood flow arrest during endovascular thrombectomy, compared to no flow arrest, did not significantly improve the vessel recanalization rates at the end of the endovascular procedure. However, a lower rate of emboli to a new vascular territory and a higher rate of complete recanalization after the first thrombectomy attempt were achieved in with temporary blood flow arrest compared to no flow arrest.REC name
Wales REC 3
REC reference
21/WA/0199
Date of REC Opinion
22 Jun 2021
REC opinion
Favourable Opinion