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OpenTrials
Completed

NCT Number: NCT03311360

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

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.

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Key information

Conditions

Vertebral Artery Origin Stenosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Drug-coated Balloon

Device

Orchid and Dahlia DCB

Bare Metal Stent

Device

any type of bare metal stent

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

  1. lumen loss at 6 months

    Time frame: 6 months

    lumen loss measured by doppler untrasound

  2. lumen loss at 12 months

    Time frame: 12 months

    lumen loss measured by doppler untrasound

  3. restenosis at 6 months

    Time frame: 6 months

    restenosis was assessed by doppler untrasound

  4. restenosis at 12 months

    Time frame: 12 months

    restenosis was assessed by doppler untrasound

  5. traget lesion revascularizition at 12 months

    Time frame: 12 months

    traget lesion revascularizition including envascular intervention and Surgery

  6. Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days

    Time frame: 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

  7. stent fracture rate at 12 months

    Time frame: 12 months

    stent fracture was assessed by DSA

Sponsors and collaborators

Lead sponsor

Chinese Society of Interventional Radiology

Other

Registry information

Official study title

Chinese Society of Interventional Radiology

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2017
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.