Vertebral Artery StenosisNCT00172458
Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents
An observational study of Vertebral Artery Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar insufficiency (VBI). It is also an important embolic source to the posterior brain. The most frequently involved location is the proximal part of the vessel, including the ostium. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Vertebral Artery Stenosis
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients with symptomatic vertebral artery stenosis treated by stenting
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hesien-Li Kao, MD, 886-2-23123456 ext. 5874, hsienlie_kao@yahoo.com
About this study
Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar insufficiency (VBI). It is also an important embolic source to the posterior brain. The most frequently involved location is the proximal part of the vessel, including the ostium. Various surgical procedures have been described for the treatment of proximal VAS with symptoms refractory to medical therapy, but all are technically difficult with high operative mortality and morbidity.
Endovascular intervention has been described as an alternative to surgery. Balloon angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon angioplasty, and primary stenting have been shown to be safe and effective with lower restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the artery and location of the lesion. Recently, Albuquerque et al. reports a relative high restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue regarding the patients' quality of life. However, there is no clinical parameter to predict restenosis of VAS. The purpose of this study is to evaluate the clinical results of our series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary stents. We sought to identify predictors of restenosis.
This is a clinical observation study. Only chart review and angiographic review will be performed.
- Conditions
- Vertebral Artery Stenosis
- Medical subject headings
- Vertebrobasilar Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Artery StenosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hesien-Li Kao, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172458
- Sponsor's protocol ID
- 9361700454
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents
- ClinicalTrials.gov ID
- NCT00172458
- Acronym / sponsor ID
- 9361700454
- Conditions
- Vertebral Artery Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- First posted
- 15 Sep 2005 (estimated)
- 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.
Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar insufficiency (VBI). It is also an important embolic source to the posterior brain. The most frequently involved location is the proximal part of the vessel, including the ostium. Various surgical procedures have been described for the treatment of proximal VAS with symptoms refractory to medical therapy, but all are technically difficult with high operative mortality and morbidity.
Endovascular intervention has been described as an alternative to surgery. Balloon angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon angioplasty, and primary stenting have been shown to be safe and effective with lower restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the artery and location of the lesion. Recently, Albuquerque et al. reports a relative high restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue regarding the patients' quality of life. However, there is no clinical parameter to predict restenosis of VAS. The purpose of this study is to evaluate the clinical results of our series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary stents. We sought to identify predictors of restenosis.
This is a clinical observation study. Only chart review and angiographic review will be performed.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic vertebral artery stenosis treated by stenting
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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. This study is not recruiting at the moment.
Hesien-Li Kao, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Artery Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesien-Li Kao, MD (886-2-23123456 ext. 5874, hsienlie_kao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 15 Sep 2005.