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Improvement of endovascular treatment for stenosis of ostial vertebral artery

Clinical Study of Endovascular Treatment for Stenosis of Ostial Vertebral Artery - Endovascular Treatment for Stenosis of Ostial Vertebral Artery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065263
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stenosis of ostial vertebral artery

Interventions

Group-Interventions:Endovascular treatment of Ostial vertebral artery (stent implantation or drug coated balloon angioplasty)

Sponsors

Beijing Huaxin Hospital(First Hospital of Tsinghua University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Symptomatic (transient ischemic attack of vertebral artery system or non disabling stroke) a) Obvious bilateral vertebral artery stenosis >= 60% or unilateral >= 70%; b) Non confluent vertebral artery stenosis >= 60%; 2. Asymptomatic a) The dominant vertebral artery stenosis >= 80%; b) Obvious stenosis of vertebral artery with evidence of hypoperfusion of posterior fossa or decrease of cerebral blood flow reserve at rest is considered to have the risk of infarction and needs treatment; c) There is obvious stenosis and it is necessary to provide collateral circulation for other vessels (such as carotid artery occlusion); d) Lesions with greater stenosis (stenosis >= 70%) or progression of stenosis will increase the risk of stroke, which can benefit from treatment, especially the dominant vertebral artery or single vertebral artery disease; 3. For the extensive lesions of cerebral arteries, especially the occlusion of one or both internal carotid arteries, the patient has the symptoms of global cerebral ischemia. For such patients, the carotid artery cannot be revascularized, and the reconstruction of the narrow vertebral artery can increase the blood supply of the whole brain through collateral circulation; 4. The patient agrees and signs the informed consent form for clinical research;

Exclusion criteria

Exclusion criteria: 1. Vertebral artery diameter5cm; 3. Severe stenosis of intracranial segment of vertebral artery, basilar artery and its branches; 4. Thrombotic stenosis; 5. Flow limiting dissection appeared after pre expansion of common balloon; 6. The expansion of stenosis lesions after conventional balloon angioplasty was still unsatisfactory; 7. Serious disability caused by stroke or dementia, especially those unable to cooperate with surgery; 8. Intracranial hemorrhage history within 30 days; 9. Severe dysfunction of heart, liver and kidney; 10. Severe coagulation dysfunction; 11. Patients with malignant tumor had bone marrow suppression after chemotherapy or radiotherapy; 12. Intracranial tumor, arteriovenous malformation, aneurysm; 13. Unable to cooperate with follow-up; 14.History of ipsilateral stroke within 4-6 weeks; 15.Refusal to participate in the clinical study due to various reasons

Design outcomes

Primary

MeasureTime frame
Dynamic changes of tortuous angle of vertebral artery in initial segment during biphasic angiography;tortuous angle of static vertebral artery;Restenosis rate of vertebral artery;Data of Stent;Data of Drug balloon;

Countries

China

Contacts

Public ContactFeng Tang

Beijing Huaxin Hospital(First Hospital of Tsinghua University)

pumctf@126.com+86 18610810303

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026