Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Vertebral Artery Stenosis Clinical Trial

Official title:

Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504657
• Other study ID #: FAHZU-2018-006
• Status: Recruiting
• Phase: Phase 2
• Start date: May 3, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2018
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Chuanjie Wu, MD
• Phone: 008618911366882
• Email: wuchuanjie8557[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months

• Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis =50%

• Lesion length of the stenosis >5mm.

• Angioplasty can be performed within two weeks after randomization

• Female subjects of childbearing potential have a negative pregnancy test.

• Signed informed consent prior to entering study

Exclusion Criteria:

• Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)

• Life expectancy shorter than 2 years

• Vertebral artery stenosis caused by dissection

• Vertebral stenting felt to be technically impracticable

• Previous stenting in randomized artery

• Pre-morbid modified Rankin scale score of greater than 3

• Currently participating or previously participated in any investigational drug or device study within 6 months.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Device:
• Drug-coated balloon angioplasty
Angioplasty with a drug-coated angioplasty
• stenting angioplasty
Angioplasty with a stenting

Locations

Country	Name	City	State
China	Nanyang City Center Hospital	Nanyang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious adverse events		30 days
Primary	Restenosis		12 months
Secondary	The composite of vascular death, myocardial infarction, or any stroke		within 30 days after the start of treatment
Secondary	The composite of vascular death, myocardial infarction, or any stroke		within 12 months after the start of treatment
Secondary	Death resulting from any cause		12 months
Secondary	Stroke in the supply territory of the symptomatic vertebral artery		12 months