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

NCT06614972 | Not Yet Recruiting

• 1 other identifier: LY2024-188-B
• Study Type: observational
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atheroscleroses, Cerebral; Intracranial Atherosclerosis; Ischemia Stroke

Keywords

Intracranial Atherosclerosis Stroke; Drug-eluting stent

Outcome Measures

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.

  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.

  12 months after implantation

Secondary Outcomes (5)

• Any cerebral events within 1 year

  12 months after implantation

• Periprocedural events

  within 30 days after implantation

• In-stent restenosis(ISR) rate

  12 months after implantation

• Technique success rate

  During the procedure

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

  Every year after implantation during 5 years

Other Outcomes (2)

• In-stent restenosis(ISR) rate

  2-5 years after implantation

• Any cerebral events

  2-5 years after implantation

Study Arms (1)

balloon-expandable drug-eluting stent

Patients were treated with balloon-expandable drug-eluting stent.

Device: Balloon-expandable drug-eluting stent

Interventions

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.

balloon-expandable drug-eluting stent

Eligibility Criteria

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

Study Population

Patients with 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%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Jieqing Wan

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yameng Sun

CONTACT

+86-13621603083; Frank_sym@163.com

Wenhua Sun

CONTACT

+86-15000029306; tennis_sun@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 26, 2024
• Study Start: September 30, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 26, 2024

Record last verified: 2024-09