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

Chinese Society of Interventional Radiology

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Artery Origin Stenosis
• Intervention / Treatment: Device: drug-coated balloon; Device: bare metal stent

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Anzhen Hospital
  • Beijing, China
    • The rockets army general hospital
  • Dalian, China
    • The First Affiliated Hospital of Dalian Medical University
  • Harbin, China
    • The First Affiliated Hospital of Harbin Medical University
  • Jilin, China
    • The First Hospital of Jilin University
  • Shenyang, China
    • Shengjing Hosptal of china medical university
  • Zhengzhou, China
    • Henan Provincial Peoples Hospital
  • Zhengzhou, China
    • The first hospital of zhengzhou university
  • Zhengzhou, China
    • Zhengzhou center hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
drug-coated balloon; patients with vertebral artery origin stenosis treated with drug-coated balloons	Device: drug-coated balloon; Orchid and Dahlia DCB
bare metal stent; patients with vertebral artery origin stenosis treated with bare metal stent	Device: bare metal stent; any type of bare metal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
lumen loss at 6 months	lumen loss measured by doppler untrasound	6 months
lumen loss at 12 months	lumen loss measured by doppler untrasound	12 months
restenosis at 6 months	restenosis was assessed by doppler untrasound	6 months
restenosis at 12 months	restenosis was assessed by doppler untrasound	12 months
traget lesion revascularizition at 12 months	traget lesion revascularizition including envascular intervention and Surgery	12 months
Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days	safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke diagnosed by investigators within 30 days after start of the treatment	30 days
stent fracture rate at 12 months	stent fracture was assessed by DSA	12 months

Collaborators and Investigators

• Sponsor: Chinese Society of Interventional Radiology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: drug-coated balloon; stenting; medical treatment; vertebral artery origin stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: CSIR01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No