Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients (ESCAPE)

Capital Medical University

Status and phase

Unknown

Phase 2

Conditions

Stroke

Mechanical Thrombectomy

Balloon Guide Catheter

Treatments

Device: Non-balloon guide catheter

Device: Balloon guide catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03754738

2018-ESCAPE

Details and patient eligibility

About

With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. A number of retrospective studies have demonstrated that flow arrest during the clot retrieval process results in less clot fragmentation, lower rates of distal emboli, higher revascularization rates and improved rates of good neurological outcome.

Enrollment

155 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older
A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more.
Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA.
Treatment can be initiated (groin puncture) within 6 hours of symptom onset.
Planning to mechanical thrombectomy with a stenting retriever.
Signed informed consent prior to entering study.

Exclusion criteria

Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial carotid artery.
Previously deployed stents in the ipsilateral carotid artery.
Dissections of the ipsilateral carotid artery.
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
Baseline platelet count < 50.000/µL.
Baseline blood glucose of < 50mg/dL or >400mg/dl.
Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg).
Renal insufficiency with creatinine ≥ 3 mg/dl.
Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
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.