Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis

Ischemic Stroke Clinical Trial

Official title:

Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis in Real-World Clinical Observations: a Prospective, Multicenter, Open-access, Single-arm Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644314
• Other study ID #: NFEC-2022-410
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 31, 2029

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Zhong Ji, PHD
• Phone: 020-62787664
• Email: jizhong22[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, open-access, single-arm trial to observe the real-world clinical efficacy of drug-eluting vertebral artery stenting system treatment for Atherosclerotic Vertebral Arteries Stenosis. Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 1 year within 3 years.

Description:

Stroke has been one of the most important causes of disability and death worldwide today. Ischemic stroke accounts for more than 50% of these strokes. The results of epidemiological surveys show that in 2018, more than 3 million new strokes occurred each year in China. In 2018, more than 3 million people suffered from a stroke, and more than 2 million people died from a stroke. Studies show that about 25% to 40% of transient ischemic attacks (TIA) or strokes occur in the posterior circulation. The subclavian and vertebral arteries are important blood vessels in the posterior circulation and are important original sites for ischemic strokes in the posterior circulation. About 20% of strokes in the posterior circulation are caused by extracranial vertebral artery stenosis (ECVAS). Endovascular intervention is the recommended treatment for ECVAS. It is effective in promoting the perfusion of brain tissue in the area of the responsible artery, thereby reducing the risk of stroke recurrence, improving neurological prognosis, and reducing symptoms. The drug-eluting stent is effective in reducing the incidence of postoperative restenosis (ISR), thus further reducing the long-term risk of stroke. Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials. The purpose of this study is to further investigate its long-term effectiveness in treating vertebral artery stenosis in the real world.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: May 31, 2029
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old, gender is not limited;

2. Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;

3. Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Unable to receive dual antiplatelet therapy due to known disease, or severe coagulation abnormalities, severe infections that are not controlled, severe systemic disease, uncontrollable hypertension, and contraindicated for surgery;

2. With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;

3. Gastrointestinal disease with active bleeding;

4. Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;

5. Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;

6. Life expectancy less than 12 months;

7. the investigator judged patients to be unsuitable for participation in this study.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Ischemic Stroke
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Device:
• The drug-eluting stent
Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (16)

Antoniou GA, Murray D, Georgiadis GS, Antoniou SA, Schiro A, Serracino-Inglott F, Smyth JV. Percutaneous transluminal angioplasty and stenting in patients with proximal vertebral artery stenosis. J Vasc Surg. 2012 Apr;55(4):1167-77. doi: 10.1016/j.jvs.201 — View Citation

Caplan LR, Amarenco P, Rosengart A, Lafranchise EF, Teal PA, Belkin M, DeWitt LD, Pessin MS. Embolism from vertebral artery origin occlusive disease. Neurology. 1992 Aug;42(8):1505-12. doi: 10.1212/wnl.42.8.1505. — View Citation

Carrera E, Maeder-Ingvar M, Rossetti AO, Devuyst G, Bogousslavsky J; Lausanne Stroke Registry. Trends in risk factors, patterns and causes in hospitalized strokes over 25 years: The Lausanne Stroke Registry. Cerebrovasc Dis. 2007;24(1):97-103. doi: 10.115 — View Citation

Che WQ, Dong H, Jiang XJ, Peng M, Zou YB, Xiong HL, Yang YJ, Gao RL. Clinical outcomes and influencing factors of in-stent restenosis after stenting for symptomatic stenosis of the vertebral V1 segment. J Vasc Surg. 2018 Nov;68(5):1406-1413. doi: 10.1016/ — View Citation

Gulli G, Khan S, Markus HS. Vertebrobasilar stenosis predicts high early recurrent stroke risk in posterior circulation stroke and TIA. Stroke. 2009 Aug;40(8):2732-7. doi: 10.1161/STROKEAHA.109.553859. Epub 2009 May 28. — View Citation

Gulli G, Marquardt L, Rothwell PM, Markus HS. Stroke risk after posterior circulation stroke/transient ischemic attack and its relationship to site of vertebrobasilar stenosis: pooled data analysis from prospective studies. Stroke. 2013 Mar;44(3):598-604. — View Citation

Langwieser N, Buyer D, Schuster T, Haller B, Laugwitz KL, Ibrahim T. Bare metal vs. drug-eluting stents for extracranial vertebral artery disease: a meta-analysis of nonrandomized comparative studies. J Endovasc Ther. 2014 Oct;21(5):683-92. doi: 10.1583/1 — View Citation

Lee JM, Park J, Kang J, Jeon KH, Jung JH, Lee SE, Han JK, Kim HL, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta- — View Citation

Li J, Hua Y, Needleman L, Forsberg F, Eisenbray JR, Li Z, Liu R, Tian X, Jiao L, Liu JB. Arterial occlusions increase the risk of in-stent restenosis after vertebral artery ostium stenting. J Neurointerv Surg. 2019 Jun;11(6):574-578. doi: 10.1136/neurints — View Citation

Li L, Wang X, Yang B, Wang Y, Gao P, Chen Y, Zhu F, Ma Y, Chi H, Zhang X, Bai X, Feng Y, Dmytriw AA, Hong T, Hua Y, Jiao L, Ling F. Validation and comparison of drug eluting stent to bare metal stent for restenosis rates following vertebral artery ostium — View Citation

Maciejewski DR, Pieniazek P, Tekieli L, Paluszek P, Przewlocki T, Tomaszewski T, Machnik R, Trystula M, Legutko J, Kablak-Ziembicka A. Comparison of drug-eluting and bare metal stents for extracranial vertebral artery stenting. Postepy Kardiol Interwencyj — View Citation

Markus HS, Harshfield EL, Compter A, Kuker W, Kappelle LJ, Clifton A, van der Worp HB, Rothwell P, Algra A; Vertebral Stenosis Trialists' Collaboration. Stenting for symptomatic vertebral artery stenosis: a preplanned pooled individual patient data analys — View Citation

Marquardt L, Kuker W, Chandratheva A, Geraghty O, Rothwell PM. Incidence and prognosis of > or = 50% symptomatic vertebral or basilar artery stenosis: prospective population-based study. Brain. 2009 Apr;132(Pt 4):982-8. doi: 10.1093/brain/awp026. Epub 200 — 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. — View Citation

Tank VH, Ghosh R, Gupta V, Sheth N, Gordon S, He W, Modica SF, Prestigiacomo CJ, Gandhi CD. Drug eluting stents versus bare metal stents for the treatment of extracranial vertebral artery disease: a meta-analysis. J Neurointerv Surg. 2016 Aug;8(8):770-4. — View Citation

Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 201 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinical ischemic events	Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion	within 1 year
Secondary	Clinical Success Rate	Successful arrival and release of the stent in the target lesion with complete coverage of the lesion and residual stenosis <30%, no major adverse events (MAE).	within 1 year after surgery
Secondary	Major adverse event (MAE) incidence	Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Incidence of bleeding events	Access or non access site bleeding	30 days and 1 year
Secondary	Incidence of in-stent restenosis	Restenosis: in-stent stenosis rate =50% on imaging	within 1 year
Secondary	Changes in the modified Rankin scale (mRS) scores	ability to perform daily living,mRS scores ranges 0-6 , the more score the more severe outcome	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Change in NIHSS scores	NIHSS scores for neurological deficits	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Correlation of risk factors with the occurrence of major adverse events	Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Correlation of risk factors with the occurrence of restenosis	Thrombosis in study stents	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Evaluation of clinical use for relative contraindications	Evaluation of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion for contraindications patients	1 month, 6 months, 12 months, 2 and 3 years