Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE)

NHS Trust

Status: Completed

Conditions: Stroke; Occlusion, Cerebrovascular

Treatments: Procedure: Endovascular thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05020795

21DI004

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 middle cerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), or digital subtraction angiography (DSA).
• ASPECTS score of >4 or by locally accepted ischaemic core/penumbra mismatch using computed 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 criteria

• Severe stenosis (>90%), or tandem occlusion of the ipsilateral extracranial internal carotid 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, visitor from overseas).
• Subject participating in a study involving an investigational drug or device that would impact this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

134 participants in 2 patient groups

Balloon inflation

Experimental group

Description:

Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter

Treatment:

Procedure: Endovascular thrombectomy

No balloon inflation

Active Comparator group

Description:

Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter

Treatment:

Procedure: Endovascular thrombectomy