Adverse Event Clinical Trial
Official title:
Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stent Angioplasty :A Prospective, Multicenter, Randomized Controlled Trial
This is a prospective single-center,randomized controlled trial,aiming to investigate the safety and efficacy of distal EPD in vertebral artery origin stenting(VAOS);256 subjects will be recruited in this study,after randomized recruitment, treatment group(128 subjects each group) undergo VAOS with adjuvant distal embolic protection device(EPD),control group undergo routine VAOS without distal embolic protection device.Intraprocedural and postprocedural in-hospital adverse events,including stroke,death and dis-retrieval of EPD,will be noted and cost-effectiveness analysis also will be conduct,including economic cost,hospital stays.
Status | Recruiting |
Enrollment | 256 |
Est. completion date | July 1, 2020 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Aged 40 to 80 years old; 2. VAO atherosclerotic stenosis results in posterior circulation ischemic symptom refractory to best medical treatment; 3. symptomatic VAO atherosclerotic stenosis>70% evaluated by computed tomograph angiography(CTA) or Magnetic Resonance Angiography(MRA) or digital subtraction angiography(DSA); 4. the diameter of the normal segment of the artery beyond the stenosis >3.5mm; 5. written informed consent. Exclusion Criteria: 1. VAO stenosis is combined with ipsilateral vertebrobasilar disease including severe cranial vertebral artery stenosis and severe basilar artery stenosis. 2. VAO is occluded; 3. Patients who will be underwent bilateral VAOS due to bilateral VAO stenosis including someone with bilateral VAO stenosis >70% and the patient who need contralateral VAOS after stenting in unilateral VAO due to recurrent posterior circulation ischemia refractory to best medical treatment. 4. VAO stenosis caused by arteritis,artery dissection, aplasia, vasculopathy caused by radiotherapy etc, other than atherosclerosis; 5. stroke within 30 days or myocardial infarction within 6 months; 6. contraindication of anticoagulant and antiplatelet agents; allergy to iodinated contrast agent; 7. severe comorbid diseases and intolerant to procedure; patient unlikely to cooperate with the procedure or provide informed consent. 8. High risk of difficulty or failure in EPD advance and retrieval due to the tortuosity of the culprit vertebral artery origin. |
Country | Name | City | State |
---|---|---|---|
China | XuanWu hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Albuquerque FC, Fiorella D, Han P, Spetzler RF, McDougall CG. A reappraisal of angioplasty and stenting for the treatment of vertebral origin stenosis. Neurosurgery. 2003 Sep;53(3):607-14; discussion 614-6. — View Citation
Borhani Haghighi A, Edgell RC, Cruz-Flores S, Zaidat OO. Vertebral artery origin stenosis and its treatment. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):369-76. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.007. Review. — View Citation
Bornak A, Milner R. Current debate on the role of embolic protection devices. Vasc Endovascular Surg. 2012 Aug;46(6):441-6. doi: 10.1177/1538574412452160. Epub 2012 Jun 21. — View Citation
Cardaioli P, Giordan M, Panfili M, Chioin R. Complication with an embolic protection device during carotid angioplasty. Catheter Cardiovasc Interv. 2004 Jun;62(2):234-6. — View Citation
Compter A, van der Worp HB, Schonewille WJ, Vos JA, Algra A, Lo TH, Mali WP, Moll FL, Kappelle LJ. VAST: Vertebral Artery Stenting Trial. Protocol for a randomised safety and feasibility trial. Trials. 2008 Nov 24;9:65. doi: 10.1186/1745-6215-9-65. — View Citation
Divani AA, Berezina TL, Zhou J, Pakdaman R, Suri MF, Qureshi AI. Microscopic and macroscopic evaluation of emboli captured during angioplasty and stent procedures in extracranial vertebral and internal carotid arteries. J Endovasc Ther. 2008 Jun;15(3):263 — View Citation
Dodevski A, Lazareska M, Tosovska-Lazarova D, Zhivadinovik J, Aliji V. Morphological characteristics of the first part of the vertebral artery. Prilozi. 2011;32(1):173-88. — View Citation
Edgell RC, Zaidat OO, Gupta R, Abou-Chebl A, Linfante I, Xavier A, Nogueira R, Alshekhlee A, Kalia J, Etezadi V, Aghaebrahim N, Jovin T. Multicenter study of safety in stenting for symptomatic vertebral artery origin stenosis: results from the Society of — View Citation
Gensicke H, Zumbrunn T, Jongen LM, Nederkoorn PJ, Macdonald S, Gaines PA, Lyrer PA, Wetzel SG, van der Lugt A, Mali WP, Brown MM, van der Worp HB, Engelter ST, Bonati LH; ICSS-MRI Substudy Investigators. Characteristics of ischemic brain lesions after ste — View Citation
Hatano T, Tsukahara T, Miyakoshi A, Arai D, Yamaguchi S, Murakami M. Stent placement for atherosclerotic stenosis of the vertebral artery ostium: angiographic and clinical outcomes in 117 consecutive patients. Neurosurgery. 2011 Jan;68(1):108-16; discussi — View Citation
Lin YH, Juang JM, Jeng JS, Yip PK, Kao HL. Symptomatic ostial vertebral artery stenosis treated with tubular coronary stents: clinical results and restenosis analysis. J Endovasc Ther. 2004 Dec;11(6):719-26. — View Citation
Mas JL, Chatellier G, Beyssen B; EVA-3S Investigators. Carotid angioplasty and stenting with and without cerebral protection: clinical alert from the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trial. St — View Citation
Mintz EP, Gruberg L, Kouperberg E, Beyar R. Vertebral artery stenting using distal emboli protection and transcranial Doppler. Catheter Cardiovasc Interv. 2004 Jan;61(1):12-5. — View Citation
Qureshi AI, Kirmani JF, Harris-Lane P, Divani AA, Ahmed S, Ebrihimi A, Al Kawi A, Janjua N. Vertebral artery origin stent placement with distal protection: technical and clinical results. AJNR Am J Neuroradiol. 2006 May;27(5):1140-5. — View Citation
Stayman AN, Nogueira RG, Gupta R. A systematic review of stenting and angioplasty of symptomatic extracranial vertebral artery stenosis. Stroke. 2011 Aug;42(8):2212-6. doi: 10.1161/STROKEAHA.110.611459. Epub 2011 Jun 23. Review. — View Citation
Taylor RA, Siddiq F, Memon MZ, Qureshi AI, Vazquez G, Hayakawa M, Chaloupka JC. Vertebral artery ostial stent placement for atherosclerotic stenosis in 72 consecutive patients: clinical outcomes and follow-up results. Neuroradiology. 2009 Aug;51(8):531-9. — View Citation
Thompson MC, Issa MA, Lazzaro MA, Zaidat OO. The natural history of vertebral artery origin stenosis. J Stroke Cerebrovasc Dis. 2014 Jan;23(1):e1-4. doi: 10.1016/j.jstrokecerebrovasdis.2012.12.004. Epub 2013 Jan 16. — View Citation
Wityk RJ, Chang HM, Rosengart A, Han WC, DeWitt LD, Pessin MS, Caplan LR. Proximal extracranial vertebral artery disease in the New England Medical Center Posterior Circulation Registry. Arch Neurol. 1998 Apr;55(4):470-8. — View Citation
Zavala-Alarcon E, Emmans L, Little R, Bant A. Percutaneous intervention for posterior fossa ischemia. A single center experience and review of the literature. Int J Cardiol. 2008 Jun 23;127(1):70-7. Epub 2007 Jul 24. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | embolus capture rate in patients treated with VAO stenting with EPD | embolus capture rate is calculate by number of patients with embolus in EPD divided number of patients without embolus in EPD in EPD group | during procedure | |
Secondary | incidence of ischemic stroke in the two group | number of patients with or without ischemic stroke in posterior circulationcirculation territory will be collected in EPD group | 30 days after procedure | |
Secondary | incidence of disable or fatal ischemic stroke in EPD group | number of patients who present disable of fatal ischemic stroke in posterior | 1 month after procedure |
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