Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study

NCT03311360 | Completed

• 1 other identifier: CSIR01
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 9

Brief Summary

There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.

Conditions

Vertebral Artery Origin Stenosis

Keywords

vertebral artery origin stenosis; drug-coated balloon; stenting; medical treatment

Outcome Measures

Primary Outcomes (1)

• Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months

  vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician

  12 months

Secondary Outcomes (7)

• lumen loss at 6 months

  6 months

• lumen loss at 12 months

  12 months

• restenosis at 6 months

  6 months

• restenosis at 12 months

  12 months

• traget lesion revascularizition at 12 months

  12 months

Study Arms (2)

drug-coated balloon

patients with vertebral artery origin stenosis treated with drug-coated balloons

Device: drug-coated balloon

bare metal stent

patients with vertebral artery origin stenosis treated with bare metal stent

Device: bare metal stent

Interventions

drug-coated balloon DEVICE

Orchid and Dahlia DCB

drug-coated balloon

bare metal stent DEVICE

any type of bare metal stent

bare metal stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients meet all of the inclusion criteria and none of the excusion criteria

You may qualify if:

• aged between 18 and 80 years old;
• TIA or non-disabling ischaemic stroke of the posterior circulation;
• symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
• stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
• NIHSS≤ 6;
• score on the modified Rankin scale ≤ 3.

You may not qualify if:

• Active bleeding or coagulation disorders or severe renal/liver impairment
• allergy to iodinated contrast agent or related medicines;
• acute stroke in 3 weeks
• more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
• a potential cause of stenosis other than atherosclerosis
• Severe stenosis was found in the anterior circulation artery(\>70%)
• intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days;
• ISR patients;
• Severe calcification lesion；
• obvious thrombosis in vessel;
• pregnancy;
• a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.

Sponsors & Collaborators

• Chinese Society of Interventional Radiology: lead

Study Sites (9)

Beijing Anzhen hospital

Beijing, China

Location

The rockets army general hospital

Beijing, China

Location

The first affiliated hospital of Dalian medical university

Dalian, China

Location

The first affiliated hospital of Harbin medical university

Harbin, China

Location

The first hospital of Jilin university

Jilin, China

Location

Shengjing Hosptal of china medical university

Shenyang, China

Location

Henan provincial peoples hospital

Zhengzhou, China

Location

The first hospital of zhengzhou university

Zhengzhou, China

Location

Zhengzhou center hospital

Zhengzhou, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 17, 2017
• Study Start: January 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 3, 2021

Record last verified: 2019-01

Locations

CN (9)