Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment

Stroke Due to Basilar Artery Occlusion Clinical Trial

— BEST  

Official title:

Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441556
• Other study ID #: JLH-NEURO-2015-001
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 30, 2017

Study information

• Verified date: December 2016
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 30, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cerebrovascular Accidents
• Arterial Occlusive Diseases
• Stroke
• Stroke Due to Basilar Artery Occlusion

Intervention

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.

Locations

Country	Name	City	State
China	123rd Hospital of The People's Liberation Army	Bengbu	Anhui
China	Changsha Central Hospital	Changsha	Hunan
China	Chengdu Military General Hospital	Chengdu	Sichuan
China	Sichuan People's Hospital	Chengdu	Sichuan
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing
China	Xinqiao Hospital, the Third Military Medical University	Chongqing
China	Fuzhou General Hospital of Nanjing Military Region	Fuzhou	Fujian
China	Guangdong No.2 Provincial People's Hospital	Guangzhou	Guangdong
China	The Chinese Armed Police Force Guangdong Armed Police Corps hospital	Guangzhou	Guangdong
China	the First People's Hospital of Hangzhou,Nanjing Medical University	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
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	Linyi People's Hospital	Linyi	Shandong
China	Lishui Central Hospital	Lishui	Zhejiang
China	Lu'an Affiliated Hospital of Anhui Medical University	Lu'an	Anhui
China	Maoming People's Hospital	Maoming	Guangdong
China	Mianyang Central Hospital	Mianyang	Sichuan
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	Jiangsu
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shenzhen Nanshan Hospital	Shenzhen	Guangdong
China	Taian City Central Hospital	Taian	Shandong
China	Hubei Zhongshan Hospital	Wuhan	Hubei
China	Wuhan No.1 Hospital	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui
China	101st hospital of PLA	Wuxi	Jiangsu
China	175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University	Xiamen	Fujian
China	Affiliated Zhongshan Hospital of Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	the Second Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	the Third People's Hospital of Yancheng	Yancheng	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	the First People's Hospital of Yangzhou, Yangzhou University	Yangzhou	Jiangsu
China	Yangzhou Hongquan Hospital	Yangzhou	Jiangsu
China	Yangzhou No.1 People's Hospital	Yangzhou	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Henan Provincial People's Hospital,Zhengzhou University	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Xinfeng Liu

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View Citation

Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA; Interventional Management of Stroke (IMS) III Investigators. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013 Mar 7;368(10):893-903. doi: 10.1056/NEJMoa1214300. Epub 2013 Feb 7. Erratum in: N Engl J Med. 2013 Mar 28;368(13):1265. — View Citation

Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E; SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):904-13. doi: 10.1056/NEJMoa1213701. Epub 2013 Feb 6. — View Citation

Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656. — View Citation

Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31. — View Citation

Kidwell CS, Jahan R, Gornbein J, Alger JR, Nenov V, Ajani Z, Feng L, Meyer BC, Olson S, Schwamm LH, Yoo AJ, Marshall RS, Meyers PM, Yavagal DR, Wintermark M, Guzy J, Starkman S, Saver JL; MR RESCUE Investigators. A trial of imaging selection and endovascular treatment for ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):914-23. doi: 10.1056/NEJMoa1212793. Epub 2013 Feb 8. — View Citation

Mattle HP, Arnold M, Lindsberg PJ, Schonewille WJ, Schroth G. Basilar artery occlusion. Lancet Neurol. 2011 Nov;10(11):1002-14. doi: 10.1016/S1474-4422(11)70229-0. Review. — View Citation

National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. — View Citation

Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26. Erratum in: Lancet. 2012 Oct 6;380(9849):1230. — View Citation

Saqqur M, Uchino K, Demchuk AM, Molina CA, Garami Z, Calleja S, Akhtar N, Orouk FO, Salam A, Shuaib A, Alexandrov AV; CLOTBUST Investigators. Site of arterial occlusion identified by transcranial Doppler predicts the response to intravenous thrombolysis for stroke. Stroke. 2007 Mar;38(3):948-54. Epub 2007 Feb 8. — View Citation

Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26. — View Citation

Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3. — View Citation

Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; Multi MERCI Investigators, Frei D, Grobelny T, Hellinger F, Huddle D, Kidwell C, Koroshetz W, Marks M, Nesbit G, Silverman IE. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008 Apr;39(4):1205-12. doi: 10.1161/STROKEAHA.107.497115. Epub 2008 Feb 28. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale (mRS)	A score of 0-3 will be considered as the favorable outcome.	at 90 days from randomization
Secondary	mRS score 0-2		at 90 days from randomization
Secondary	Change of mRS score(shift analysis)		at 90 days from randomization
Secondary	Vessel recanalization rate evaluated by CT angiography or MRA		at 24 hours from randomization
Secondary	PC-ASPECT score on CT/MRI		at 24 hours from randomization
Secondary	GCS score		at 24 hours from randomization
Secondary	NIHSS score		at 24 hours from randomization
Secondary	GCS score		at 5-7 days from randomization
Secondary	NIHSS score		at 5-7 days from randomization
Secondary	EuroQol 5D (EQ-5D)		at 90 days from randomization
Secondary	mortality		at 3 months from randomization
Secondary	symptomatic intracerebral hemorrhage (ICH)		within 24 hours from randomization
Secondary	incidence of non-intracerebral hemorrhage complications		at 90 days from randomization
Secondary	severity of non-intracerebral hemorrhage complications		within 90 days from randomization
Secondary	incidence of nonbleeding severe adverse events (SAEs)		within 90 days from randomization
Secondary	severity of nonbleeding severe adverse events (SAEs)		within 90 days from randomization
Secondary	incidence of procedure and device related complications	i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.	within 90 days from randomization
Secondary	severity of procedure and device related complications	i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.	within 90 days from randomization