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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device Balloon-expandable drug-eluting stent
  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 outcome measures

• 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]

Secondary outcome measures (5)

• Any cerebral events within 1 year [Time frame: 12 months after implantation]
• Periprocedural events [Time frame: within 30 days after implantation]
• In-stent restenosis(ISR) rate [Time frame: 12 months after implantation]
• Technique success rate [Time frame: During the procedure]
• Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score [Time frame: Every year after implantation during 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Li G, Wang N, Li X, Ma N, Liu T, Sun Y, Liu P, Miao Z, Zhang Y. Balloon-Mounted versus Self-Expanding Stent Outcomes in Symptomatic Middle Cerebral Artery Stenosis Combined with Poor Collaterals in China: A Multicenter Registry Study. World Neurosurg. 2019 Apr;124:e675-e681. doi: 10.1016/j.wneu.2018.12.189. Epub 2019 Jan 16. PMID 30659967
• Zhang Y, Rajah GB, Liu P, Sun Y, Liu T, Li X, Miao Z, Li G. Balloon-mounted versus self-expanding stents for symptomatic intracranial vertebrobasilar artery stenosis combined with poor collaterals. Neurol Res. 2019 Aug;41(8):704-713. doi: 10.1080/01616412.2019.1610837. Epub 2019 Apr 28. PMID 31030623
• Abdollahifard S, Yousefi O, Kamran H, Mowla A. Balloon-mounting stent for intracranial arterial stenosis: A comprehensive and comparative systematic review and meta-analysis. Interv Neuroradiol. 2023 Aug;29(4):466-480. doi: 10.1177/15910199221100620. Epub 2022 May 12. PMID 35549530
• Bartstra JW, van den Beukel TC, Van Hecke W, Mali WPTM, Spiering W, Koek HL, Hendrikse J, de Jong PA, den Harder AM. Intracranial Arterial Calcification: Prevalence, Risk Factors, and Consequences: JACC Review Topic of the Week. J Am Coll Cardiol. 2020 Sep 29;76(13):1595-1604. doi: 10.1016/j.jacc.2020.07.056. PMID 32972537
• Ma N, Zhang Y, Shuai J, Jiang C, Zhu Q, Chen K, Liu L, Li B, Shi X, Gao L, Liu Y, Wang F, Li Y, Liu T, Zheng H, Mo D, Gao F, Wang Y, Wang Y, Feng L, Miao Z. Stenting for symptomatic intracranial arterial stenosis in China: 1-year outcome of a multicentre registry study. Stroke Vasc Neurol. 2018 May 7;3(3):176-184. doi: 10.1136/svn-2017-000137. eCollection 2018 Sep. PMID 30294474

Identifiers

NCT: NCT06614972 · LY2024-188-B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗