Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon inflation | Experimental | Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter |
|
| No balloon inflation | Active Comparator | Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular thrombectomy | Procedure | Clot retrieval for large vessel occlusion in acute ischaemic stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3 | Near complete-complete vessel recanalisation | Immediately after endovascular thrombectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3 | Successful vessel recanalisation | Immediately after endovascular thrombectomy |
| First pass effect (mTICI2c-3) | Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Permesh Singh Dhillon | Nottingham University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39697177 | Derived | Dhillon PS, Butt W, Podlasek A, Bhogal P, Lynch J, Booth TC, McConachie N, Lenthall R, Nair S, Malik L, Goddard T, Carraro do Nascimento V, Barrett E, Jethwa K, Krishnan K, Dineen RA, England TJ; ProFATE Investigators. Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE): A Multicenter, Blinded-End Point, Randomized Clinical Trial. Stroke. 2025 Feb;56(2):371-379. doi: 10.1161/STROKEAHA.124.049715. Epub 2024 Dec 19. | |
| 37231682 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| During endovascular thrombectomy procedure |
| New or distal vascular territory clot embolisation | Immediately after endovascular thrombectomy |
| Modified Rankin Scale 0-2 | Good functional outcome based on the modified Rankin scale of disability | 90 days |
| Symptomatic intracranial haemorrhage | 24 hours after Endovascular thrombectomy |
| National Institutes of Health of Stroke Scale (NIHSS) | Change in stroke severity | 24 hours |
| Mortality | 90 days |
| Total number of passes at clot retrieval | Immediately after endovascular thrombectomy |
| Procedure related complications | Immediately after endovascular thrombectomy |
| Total procedural time | Immediately after endovascular thrombectomy |
| Derived |
| Dhillon PS, Butt W, Podlasek A, Bhogal P, McConachie N, Lenthall R, Nair S, Malik L, Lynch J, Goddard T, Barrett E, Krishnan K, Dineen RA, England TJ. Effect of proximal blood flow arrest during endovascular thrombectomy (ProFATE): Study protocol for a multicentre randomised controlled trial. Eur Stroke J. 2023 Jun;8(2):581-590. doi: 10.1177/23969873231166194. Epub 2023 Mar 30. |
| D002318 | Cardiovascular Diseases |