Ischemic StrokeNCT05644314
Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis
A study testing The drug-eluting stent in people with Ischemic Stroke and Vertebral Artery Stenosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Vertebral Artery Stenosis
- What is being tested?
- The drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kaibin Huang contact
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Zhong Ji, PHD, 020-62787664, jizhong22@hotmail.com
Kaibing Huang, 15915751065, hkb@smu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Stroke, Vertebral Artery Stenosis
- Being tested
- The drug-eluting stent
- Medical subject headings
- Ischemic Stroke, Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 1 year
Secondary outcomes (9)
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).
Measured: within 1 year after surgery
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.
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Incidence of bleeding events
Access or non access site bleeding
Measured: 30 days and 1 year
Incidence of in-stent restenosis
Restenosis: in-stent stenosis rate ≥50% on imaging
Measured: within 1 year
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
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Change in NIHSS scores
NIHSS scores for neurological deficits
Measured: 1 month, 6 months, 12 months, 2 and 3 years
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.
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Correlation of risk factors with the occurrence of restenosis
Thrombosis in study stents
Measured: 1 month, 6 months, 12 months, 2 and 3 years
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
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 May 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jizhong, Nanfang Hospital, Southern Medical University
- Investigators
- Zhong Ji, PHD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644314
- Sponsor's protocol ID
- NFEC-2022-410
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is proceeding.
Publications
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.
PubMed 17519551Marquardt 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.
PubMed 19293244Caplan 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.
PubMed 1641144Gulli 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.
PubMed 23386676Gulli 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.
PubMed 19478210Wang 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.
PubMed 23803136Stayman 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.
PubMed 21700936Markus 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.
PubMed 31130429Antoniou 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.
PubMed 22206680Langwieser 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.
PubMed 25290797Lee 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.
PubMed 25703886Tank 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.
PubMed 26180094Che 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.
PubMed 29789215Maciejewski 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.
PubMed 31592257Li 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.
PubMed 30337379
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05644314
- Acronym / sponsor ID
- NFEC-2022-410
- Conditions
- Ischemic Stroke, Vertebral Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with vertebral atherosclerotic stenosis requiring stent implantation | Experimental | Device: The drug-eluting stentReferring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The drug-eluting stentVertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials. | Device | Patients with vertebral atherosclerotic stenosis requiring stent implantation |
Primary outcome
Incidence of clinical ischemic events
Time frame: within 1 year
Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
9 secondary outcomes
Clinical Success Rate
Time frame: within 1 year after surgery
Major adverse event (MAE) incidence
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Incidence of bleeding events
Time frame: 30 days and 1 year
Incidence of in-stent restenosis
Time frame: within 1 year
Changes in the modified Rankin scale (mRS) scores
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Change in NIHSS scores
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Correlation of risk factors with the occurrence of major adverse events
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Correlation of risk factors with the occurrence of restenosis
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Evaluation of clinical use for relative contraindications
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Results publication: PubMed 17519551Carrera 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 publication: PubMed 19293244Marquardt 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 publication: PubMed 1641144Caplan 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 publication: PubMed 23386676Gulli 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 publication: PubMed 19478210Gulli 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 publication: PubMed 23803136Wang 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 publication: PubMed 21700936Stayman 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 publication: PubMed 31130429Markus 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 publication: PubMed 22206680Antoniou 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 publication: PubMed 25290797Langwieser 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 publication: PubMed 25703886Lee 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 publication: PubMed 26180094Tank 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.
- Individual participant dataSharing planned: No. The study is proceeding.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaibin Huang contact
Zhong Ji, PHD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The drug-eluting stent in people with Ischemic Stroke and Vertebral Artery Stenosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhong Ji, PHD (020-62787664, jizhong22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical ischemic events (time frame: within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644314, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.