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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:
ClinicalTrials.gov Identifier:
NCT02441556
First Posted: May 12, 2015
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Xinfeng Liu, Jinling Hospital, China
  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: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years;
  2. Acute ischemic stroke consistent with infarction in the basilar artery territory;
  3. Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
  4. Written informed consent from patient or surrogate, if unable to provide consent.

Exclusion Criteria:

  1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation;
  2. Premorbid mRS ≥ 3 points;
  3. Currently in pregnant or lactating;
  4. Known serious sensitivity to radiographic contrast agents and nitinol metal;
  5. Current participation in another investigation drug or device study;
  6. 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;
  7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time;
  8. Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%;
  9. Arterial tortuosity that would prevent the device from reaching the target vessel;
  10. Life expectancy less than 1 year;
  11. History of major hemorrhage in the past 6 months;
  12. Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
  13. Angiographic evidence of bilateral extended brainstem ischemia.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

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
First Submitted: April 16, 2015
First Posted: May 12, 2015
Last Update Posted: December 15, 2016
Last Verified: December 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