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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
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.
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.
modified Rankin Scale (mRS)
A score of 0-3 will be considered as the favorable outcome.
Time frame: at 90 days from randomization
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)
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123rd Hospital of The People's Liberation Army
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
the First Affiliated Hospital of An'hui Medical University
Hefei, Anhui, China
the First People's Hospital of Huainan
Huainan, Anhui, China
Lu'an Affiliated Hospital of Anhui Medical University
Lu'an, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
Xiamen, Fujian, China
...and 34 more locations
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
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Time frame: within 90 days from randomization
severity of procedure and device related complications
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Time frame: within 90 days from randomization