IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment (BEST)
This study is currently recruiting participants.
Verified December 2016 by Xinfeng Liu, Jinling Hospital, China
Sponsor:
Xinfeng Liu
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT02441556
First received: April 16, 2015
Last updated: December 13, 2016
Last verified: December 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.
| Condition | Intervention |
|---|---|
| Stroke Due to Basilar Artery Occlusion Acute Cerebrovascular Accidents | Device: endovascular treatment Other: standard medical therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment |
Further study details as provided by Xinfeng Liu, Jinling Hospital, China:
Primary Outcome Measures:
- modified Rankin Scale (mRS) [ Time Frame: at 90 days from randomization ]A score of 0-3 will be considered as the favorable outcome.
Secondary Outcome Measures:
- mRS score 0-2 [ Time Frame: at 90 days from randomization ]
- Change of mRS score(shift analysis) [ Time Frame: at 90 days from randomization ]
- Vessel recanalization rate evaluated by CT angiography or MRA [ Time Frame: at 24 hours from randomization ]
- PC-ASPECT score on CT/MRI [ Time Frame: at 24 hours from randomization ]
- GCS score [ Time Frame: at 24 hours from randomization ]
- NIHSS score [ Time Frame: at 24 hours from randomization ]
- GCS score [ Time Frame: at 5-7 days from randomization ]
- NIHSS score [ Time Frame: at 5-7 days from randomization ]
- EuroQol 5D (EQ-5D) [ Time Frame: at 90 days from randomization ]
- mortality [ Time Frame: at 3 months from randomization ]
- symptomatic intracerebral hemorrhage (ICH) [ Time Frame: within 24 hours from randomization ]
- incidence of non-intracerebral hemorrhage complications [ Time Frame: at 90 days from randomization ]
- severity of non-intracerebral hemorrhage complications [ Time Frame: within 90 days from randomization ]
- incidence of nonbleeding severe adverse events (SAEs) [ Time Frame: within 90 days from randomization ]
- severity of nonbleeding severe adverse events (SAEs) [ Time Frame: within 90 days from randomization ]
- incidence of procedure and device related complications [ Time Frame: within 90 days from randomization ]i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
- severity of procedure and device related complications [ Time Frame: within 90 days from randomization ]i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
| Estimated Enrollment: | 344 |
| Study Start Date: | January 2015 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard medical therapy
Patients receive standard medical therapy alone.
|
Other: standard medical therapy
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
|
|
Experimental: endovascular + standard medical therapy
Patients receive endovascular treatment plus standard medical therapy.
|
Device: endovascular treatment
The endovascular treatment is comprised of thrombolysis, mechanical thrombectomy, stenting, or a combination of all these approaches. Generally, Solitaire FR is preferred, other devices such as Trevo or future advanced devices can also be considered which will be decided by the executive committee.
Other: standard medical therapy
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
|
Detailed Description:
This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old.
In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥18 years;
- Acute ischemic stroke consistent with infarction in the basilar artery territory;
- Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
- Written informed consent from patient or surrogate, if unable to provide consent.
Exclusion Criteria:
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation;
- Premorbid mRS ≥ 3 points;
- Currently in pregnant or lactating;
- Known serious sensitivity to radiographic contrast agents and nitinol metal;
- Current participation in another investigation drug or device study;
- Uncontrolled hypertension defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg that cannot be controlled except with continuous parenteral antihypertensive medication;
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time;
- Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%;
- Arterial tortuosity that would prevent the device from reaching the target vessel;
- Life expectancy less than 1 year;
- History of major hemorrhage in the past 6 months;
- Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
- Angiographic evidence of bilateral extended brainstem ischemia.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02441556
Show 44 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02441556
Contacts
| Contact: Gelin Xu, Doctor | 86-25-80863531 | gelinxu@nju.edu.cn | |
| Contact: Yunyun Xiong, Doctor | 86-25-80863530 | caloriey@163.com |
Show 44 Study Locations
Sponsors and Collaborators
Xinfeng Liu
Investigators
| Study Chair: | Xinfeng Liu, Doctor | Departmnet of Neurology, Jinling Hospital |
More Information
Publications:
| Responsible Party: | Xinfeng Liu, Professor and Chairman of Department of Neurology, Jinling Hospital, China |
| ClinicalTrials.gov Identifier: | NCT02441556 History of Changes |
| Other Study ID Numbers: |
JLH-NEURO-2015-001 |
| Study First Received: | April 16, 2015 |
| Last Updated: | December 13, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Xinfeng Liu, Jinling Hospital, China:
|
thrombectomy rt-PA stroke endovascular treatment randomized |
Additional relevant MeSH terms:
|
Stroke Arterial Occlusive Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on July 14, 2017