NCT05644314

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
May 2022May 2029

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

4.1 years

First QC Date

November 16, 2022

Last Update Submit

March 13, 2023

Conditions

Ischemic StrokeVertebral Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Clinical Success Rate

    within 1 year after surgery

  • Major adverse event (MAE) incidence

    1 month, 6 months, 12 months, 2 and 3 years

  • Incidence of bleeding events

    30 days and 1 year

  • Incidence of in-stent restenosis

    within 1 year

  • Changes in the modified Rankin scale (mRS) scores

    1 month, 6 months, 12 months, 2 and 3 years

  • +4 more secondary outcomes

Study Arms (1)

Patients with vertebral atherosclerotic stenosis requiring stent implantation

EXPERIMENTAL

Referring to "the 2015 Chinese Guidelines for Endovascular Interventional Treatment of Ischemic Cerebrovascular Disease", "the 2015 Symptomatic Atherosclerotic Sclerotic vertebral artery initiation stenosis: Chinese expert consensus" and "Subclavian/extracranial vertebral artery stenosis: Chinese expert consensus" in 2019 and other guidelines and expert consensus for the diagnosis of symptomatic vertebral artery atherosclerotic stenosis ≥ 50% and non-symptomatic vertebral artery atherosclerotic stenosis ≥ 70% in patients.

Device: The drug-eluting stent

Interventions

The drug-eluting stentDEVICE

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.

Patients with vertebral atherosclerotic stenosis requiring stent implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old, gender is not limited;
  • Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;
  • Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

  • 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;
  • With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;
  • Gastrointestinal disease with active bleeding;
  • Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;
  • Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;
  • Life expectancy less than 12 months;
  • the investigator judged patients to be unsuitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (16)

  • 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: 10.1159/000103123. Epub 2007 May 23.

    PMID: 17519551RESULT

  • 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 2009 Mar 17.

    PMID: 19293244RESULT

  • 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.

    PMID: 1641144RESULT

  • 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. doi: 10.1161/STROKEAHA.112.669929. Epub 2013 Feb 5.

    PMID: 23386676RESULT

  • 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.

    PMID: 19478210RESULT

  • 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. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

    PMID: 23803136RESULT

  • 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.

    PMID: 21700936RESULT

  • 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 analysis. Lancet Neurol. 2019 Jul;18(7):666-673. doi: 10.1016/S1474-4422(19)30149-8. Epub 2019 May 23.

    PMID: 31130429RESULT

  • 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.2011.09.084. Epub 2011 Dec 28.

    PMID: 22206680RESULT

  • 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: 10.1583/14-4713MR.1.

    PMID: 25290797RESULT

  • 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-analysis of 11 randomized, controlled trials. JACC Cardiovasc Interv. 2015 Mar;8(3):382-394. doi: 10.1016/j.jcin.2014.09.023. Epub 2015 Feb 18.

    PMID: 25703886RESULT

  • 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. doi: 10.1136/neurintsurg-2015-011697. Epub 2015 Jul 15.

    PMID: 26180094RESULT

  • 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/j.jvs.2018.02.042. Epub 2018 May 19.

    PMID: 29789215RESULT

  • 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 Interwencyjnej. 2019;15(3):328-337. doi: 10.5114/aic.2019.87887. Epub 2019 Sep 18.

    PMID: 31592257RESULT

  • 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/neurintsurg-2018-014243. Epub 2018 Oct 18.

    PMID: 30337379RESULT

  • 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 stenting: A single-center real-world study. Interv Neuroradiol. 2020 Oct;26(5):629-636. doi: 10.1177/1591019920949371. Epub 2020 Aug 16.

    PMID: 32799746RESULT

MeSH Terms

Conditions

Ischemic StrokeVertebrobasilar Insufficiency

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Zhong Ji, PHD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong Ji, PHD

CONTACT

020-62787664jizhong22@hotmail.com

Kaibin Huang

CONTACT

15915751065

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 9, 2022

Study Start

May 1, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2029

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The study is proceeding.

Locations

CN(1)