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NCT Number: NCT06614972

Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)

To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.

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Key information

Conditions

Atheroscleroses, Cerebral Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Intracranial Atherosclerosis Ischemia Stroke Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • According to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%~99% (WASID method).
  • Patients have more than 1 episode of symptoms including stroke or transient ischemia attack (TIA) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments).
  • Patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on.
  • Baseline mRS score ≤3.
  • Patient or guardian signs informed consent.

Exclusion criteria

  • Patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery.
  • Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
  • Gastrointestinal disease with active bleeding.
  • Myocardial infarction or massive cerebral infarction within 2 weeks.
  • Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
  • Life expectancy <12 months.
  • According to the judgement of the investigator, other situations that are not suitable for enrollment.

Treatment and study plan

Balloon-expandable drug-eluting stent

Device

Balloon-expandable drug-eluting stent (BDES) is the device comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.

Primary outcomes

  1. Any stroke or death within 30 days of implantation or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.

    Time frame: 12 months after implantation

    Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year.

Secondary outcomes

  1. Any cerebral events within 1 year

    Time frame: 12 months after implantation

    Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery

  2. Periprocedural events

    Time frame: within 30 days after implantation

    Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death.

  3. In-stent restenosis(ISR) rate

    Time frame: 12 months after implantation

    The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss on angiographic experiment.

  4. Technique success rate

    Time frame: During the procedure

    Technique success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%.

  5. Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score

    Time frame: Every year after implantation during 5 years

    Modified Rankin Scale (mRS) score and NIHSS score(if need) at every year after implantation during 5 years. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead. A higher score indicates a worse outcome. NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The minimum score is 1 and the maximum score is 20. A higher score indicates a worse outcome.

Other outcomes

  1. In-stent restenosis(ISR) rate

    Time frame: 2-5 years after implantation

    The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss on angiographic experiment.

  2. Any cerebral events

    Time frame: 2-5 years after implantation

    Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenhua Sun

CONTACT

[email protected]

+86-15000029306

Yameng Sun

CONTACT

[email protected]

+86-13621603083

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

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.

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