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出境医 / 临床实验 / Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER) (VOTER)
Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER) (VOTER)
Study Description
Brief Summary:
A prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).
| Condition or disease | Intervention/treatment |
|---|---|
| Vertebral Artery Stenosis | Other: Observational Prospective Registry |
Detailed Description:
A prospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). Looking at clinical outcomes at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment.
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER) |
| Actual Study Start Date : | November 19, 2019 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | May 2023 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Incidence of recurrent stroke or death [ Time Frame: 1 Year post-treatment ]Recurrent stroke of any type or death from any cause
Secondary Outcome Measures :
- Incidence of Restenosis [ Time Frame: 1 Year post-treatment ]Restenosis in VAOS patients treated with drug-eluting stents.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 25, 2019 | ||||||||
| First Posted Date | June 27, 2019 | ||||||||
| Last Update Posted Date | November 27, 2020 | ||||||||
| Actual Study Start Date | November 19, 2019 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Incidence of recurrent stroke or death [ Time Frame: 1 Year post-treatment ] Recurrent stroke of any type or death from any cause
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Incidence of Restenosis [ Time Frame: 1 Year post-treatment ] Restenosis in VAOS patients treated with drug-eluting stents.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER) | ||||||||
| Official Title | Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER) | ||||||||
| Brief Summary | A prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS). | ||||||||
| Detailed Description | A prospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). Looking at clinical outcomes at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment. | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 1 Year | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS). | ||||||||
| Condition | Vertebral Artery Stenosis | ||||||||
| Intervention | Other: Observational Prospective Registry
This is a prospective registry looking at patients admitted for stroke with evidence of Vertebral Artery Origin Stenosis. Patients clinical outcomes will be collected at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment
Other Name: Observational
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 2023 | ||||||||
| Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03999983 | ||||||||
| Other Study ID Numbers | 29760 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Randall C. Edgell, MD, FSVIN, St. Louis University | ||||||||
| Study Sponsor | St. Louis University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | St. Louis University | ||||||||
| Verification Date | November 2020 | ||||||||
