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

Primary Purpose

Ischemic Stroke, Vertebral Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The drug-eluting stent
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Nanfang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with vertebral atherosclerotic stenosis requiring stent implantation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
Incidence of bleeding events
Access or non access site bleeding
Incidence of in-stent restenosis
Restenosis: in-stent stenosis rate ≥50% on imaging
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
Change in NIHSS scores
NIHSS scores for neurological deficits
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.
Correlation of risk factors with the occurrence of restenosis
Thrombosis in study stents
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

Full Information

First Posted
November 16, 2022
Last Updated
March 13, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05644314
Brief Title
Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Vertebral Artery Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with vertebral atherosclerotic stenosis requiring stent implantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The drug-eluting stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of clinical ischemic events
Description
Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
Time Frame
within 1 year
Secondary Outcome Measure Information:
Title
Clinical Success Rate
Description
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).
Time Frame
within 1 year after surgery
Title
Major adverse event (MAE) incidence
Description
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.
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Incidence of bleeding events
Description
Access or non access site bleeding
Time Frame
30 days and 1 year
Title
Incidence of in-stent restenosis
Description
Restenosis: in-stent stenosis rate ≥50% on imaging
Time Frame
within 1 year
Title
Changes in the modified Rankin scale (mRS) scores
Description
ability to perform daily living,mRS scores ranges 0-6 , the more score the more severe outcome
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Change in NIHSS scores
Description
NIHSS scores for neurological deficits
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Correlation of risk factors with the occurrence of major adverse events
Description
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.
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Correlation of risk factors with the occurrence of restenosis
Description
Thrombosis in study stents
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Evaluation of clinical use for relative contraindications
Description
Evaluation of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion for contraindications patients
Time Frame
1 month, 6 months, 12 months, 2 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong Ji, PHD
Phone
020-62787664
Email
jizhong22@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kaibin Huang
Phone
15915751065
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Ji, PHD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Ji, PHD
Phone
020-62787664
Email
jizhong22@hotmail.com
First Name & Middle Initial & Last Name & Degree
Kaibing Huang
Phone
15915751065
Email
hkb@smu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study is proceeding.
Citations:
PubMed Identifier
17519551
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: 10.1159/000103123. Epub 2007 May 23.
Results Reference
result
PubMed Identifier
19293244
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 2009 Mar 17.
Results Reference
result
PubMed Identifier
1641144
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.
Results Reference
result
PubMed Identifier
23386676
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. doi: 10.1161/STROKEAHA.112.669929. Epub 2013 Feb 5.
Results Reference
result
PubMed Identifier
19478210
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.
Results Reference
result
PubMed Identifier
23803136
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. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
Results Reference
result
PubMed Identifier
21700936
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.
Results Reference
result
PubMed Identifier
31130429
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 analysis. Lancet Neurol. 2019 Jul;18(7):666-673. doi: 10.1016/S1474-4422(19)30149-8. Epub 2019 May 23.
Results Reference
result
PubMed Identifier
22206680
Citation
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.
Results Reference
result
PubMed Identifier
25290797
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: 10.1583/14-4713MR.1.
Results Reference
result
PubMed Identifier
25703886
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-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.
Results Reference
result
PubMed Identifier
26180094
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. doi: 10.1136/neurintsurg-2015-011697. Epub 2015 Jul 15.
Results Reference
result
PubMed Identifier
29789215
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/j.jvs.2018.02.042. Epub 2018 May 19.
Results Reference
result
PubMed Identifier
31592257
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 Interwencyjnej. 2019;15(3):328-337. doi: 10.5114/aic.2019.87887. Epub 2019 Sep 18.
Results Reference
result
PubMed Identifier
30337379
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/neurintsurg-2018-014243. Epub 2018 Oct 18.
Results Reference
result
PubMed Identifier
32799746
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 stenting: A single-center real-world study. Interv Neuroradiol. 2020 Oct;26(5):629-636. doi: 10.1177/1591019920949371. Epub 2020 Aug 16.
Results Reference
result

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

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