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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03754738
Other study ID # 2018-ESCAPE
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 25, 2018
Est. completion date February 28, 2020

Study information

Verified date December 2018
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 155
Est. completion date February 28, 2020
Est. primary completion date November 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Balloon guide catheter
Use a balloon guide catheter in the mechanical thrombectomy
Non-balloon guide catheter
Use a non-balloon guide catheter in the mechanical thrombectomy

Locations

Country Name City State
China Lu He hospital, Capital Medical University Beijing Beijing
China Xuan Wu Hospital,Capital Medical University Beijing Beijing
China Shengli Oilfield Central Hospital Dongying Shandong
China Nanyang City Center Hospital Nanyang
China Suzhou Municipal Hoapital Suzhou An Hui
China The First Affiliated Hospital of Zhengzhou University Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety (occurrence of adverse events and serious adverse events) 7 days
Primary Distal embolization, After mechanical thrombectomy, usually within 3 hours
Secondary Modified thrombolysis in cerebral infarction 2b/3, After mechanical thrombectomy, usually within 3 hours
Secondary Modified thrombolysis in cerebral infarction After mechanical thrombectomy, usually within 3 hours
Secondary Modified thrombolysis in cerebral infarction 2b/3 after the first pass After the first pass, , usually within 3 hours
Secondary First pass recanalization rate After the first pass, , usually within 3 hours
Secondary Number of passes After mechanical thrombectomy, usually within 3 hours
Secondary Procedure time From the procedure start to the end, usually within 3 hours
Secondary National Institutes of Health Stroke Scale Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. 7 days or discharge
Secondary Symptomatic intracranial hemorrhage 24 hours
Secondary Modified Rankin Scale Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). 90 days
Secondary Mortality 90 days
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