150 Participants Needed

Endovascular Techniques for Narrowing of the Vertebral Artery

(VOTER Trial)

Recruiting at 10 trial locations
KC
AG
RE
MH
Overseen ByMollie Hoffmeyer, RN, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of endovascular techniques, a minimally invasive procedure, for individuals with a specific type of stroke. It targets those who have experienced a stroke in the back part of the brain and have stenosis in the vertebral arteries, which supply blood to the brain. The trial is open to participants diagnosed with more than 50% narrowing in one of these arteries and who have had a stroke event in the back part of their brain. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important research.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that endovascular techniques are safe for treating vertebral artery origin stenosis?

Research has shown that endovascular techniques are generally safe and well-tolerated. These procedures are usually minimally invasive, involving smaller incisions and typically posing less risk to patients. In one study, serious side effects occurred in about 29% of patients, with only 11% related to the device used. Another study found no significant increase in the risk of death or stroke within 30 days after treatment. These findings suggest that endovascular treatments are relatively safe, though they do carry some risks.12345

Why are researchers excited about this trial?

Endovascular techniques are unique because they allow for minimally invasive procedures to treat issues at the origin of the vertebral artery, unlike traditional open surgery methods. Researchers are excited about these techniques because they offer the potential for less recovery time and fewer complications, making them a safer alternative for patients. These approaches utilize catheters and small instruments inserted through blood vessels, providing precision in targeting the problematic artery areas without the need for large incisions.

What evidence suggests that endovascular techniques are effective for stroke with Vertebral Artery Origin Stenosis?

Research has shown that certain medical procedures, known as endovascular techniques, may help treat conditions like Vertebral Artery Origin Stenosis (VAOS), which is linked to strokes. One study found that these techniques can help patients become more independent in their daily activities three months after treatment. In one group, many patients had their blood flow successfully restored. Another study found that about 74% of patients had the affected artery completely closed off. These findings suggest that endovascular methods can effectively improve outcomes for patients with VAOS.16789

Who Is on the Research Team?

RE

Randall Edgell, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient has experienced a posterior circulation ischemic event
Patient has angiographically confirmed bilateral vertebral artery origin disease (Hypoplasia, occlusion, or stenosis).
Patient has >50% stenosis on the side being targeted for therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stenting plus medical management for Vertebral Artery Origin Stenosis (VAOS)

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Endovascular Techniques

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials
197
Recruited
41,400+

Citations

Safety and outcomes of different endovascular treatment ...The study outcomes were functional independence at 3 months after EVT (defined as a mRS score of 0–2), successful reperfusion (mTICI ≥ 2b), ...
Comparative outcomes of endovascular vs. surgical ...Periprocedural complications occurred in 21.6 % of cases. In the endovascular group, the complete occlusion rate at last follow-up was 73.6 %.
Systematic Review and Meta‐Analysis of Endovascular ...Out of the analyzed devices, the Woven EndoBridge exhibited the shortest time to achieve >90% probability of follow‐up complete occlusion (∼18 ...
Effectiveness and outcome of endovascular therapy for late ...Covered stent placement was successful in 14 of 16 patients (88%); embolization was successful in 10 of 11 (91%) patients. For the embolization group, the ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38845180/
Endovascular treatment to improve outcomes for medium ...Data from non-randomized studies suggest that endovascular treatment (EVT) may improve outcomes in MeVO stroke, but randomized data on potential benefits and ...
Safety Considerations for Endovascular SurgeryThe majority of endovascular procedures are minimally invasive with reduced risk and morbidity for the patient. However, imaging techniques, endovascular ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)The results from preclinical and clinical studies indicate that the Tack. Endovascular System® (6F) meets safety and performance specifications.
Safety and Long-Term Efficacy Outcomes for Endovascular ...Of these, a total of 15 presented as ruptured aneurysms. Serious adverse events were reported in 21 (29.2%) of patients, with 8 (11.1%) attributed to the device ...
Safety and Efficacy of Endovascular Treatment of Carotid ...Analysis of 30-day safety data found no significant difference in the odds of treatment-related death or any stroke (odds ratio [OR], ...
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