Atheroscleroses, CerebralNCT06614972
Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)
An observational study of Atheroscleroses, Cerebral and Intracranial Atherosclerosis, run by RenJi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atheroscleroses, Cerebral, Intracranial Atherosclerosis, Ischemia Stroke
- What is being tested?
- Balloon-expandable drug-eluting stent
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 30 Sep 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study
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.
Read the 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.
- Being tested
- Balloon-expandable drug-eluting stent
- Keywords
- Intracranial Atherosclerosis Stroke, Drug-eluting stent
- Medical subject headings
- Intracranial Arteriosclerosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-expandable drug-eluting stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| balloon-expandable drug-eluting stent | Patients were treated with balloon-expandable drug-eluting stent. Receives: Device: Balloon-expandable drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after implantation
Secondary outcomes (5)
Any cerebral events within 1 year
Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery
Measured: 12 months after implantation
Periprocedural events
Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death.
Measured: within 30 days after implantation
In-stent restenosis(ISR) rate
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.
Measured: 12 months after implantation
Technique success rate
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%.
Measured: During the procedure
Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score
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.
Measured: Every year after implantation during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atheroscleroses, CerebralStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jieqing Wan, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614972
- Sponsor's protocol ID
- LY2024-188-B
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Haven't decided share IPD to other researchers.
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.
PubMed 30659967Zhang 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.
PubMed 31030623Abdollahifard 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.
PubMed 35549530Bartstra 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.
PubMed 32972537Ma 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.
PubMed 30294474
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study
- ClinicalTrials.gov ID
- NCT06614972
- Acronym / sponsor ID
- LY2024-188-B
- Keywords
- Intracranial Atherosclerosis Stroke, Drug-eluting stent
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balloon-expandable drug-eluting stent | – | Device: Balloon-expandable drug-eluting stentPatients were treated with balloon-expandable drug-eluting stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon-expandable drug-eluting stentBalloon-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. | Device | balloon-expandable drug-eluting stent |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 30659967Li 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.
- Background: PubMed 31030623Zhang 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.
- Background: PubMed 35549530Abdollahifard 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.
- Background: PubMed 32972537Bartstra 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.
- Background: PubMed 30294474Ma 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.
- Individual participant dataSharing planned: Undecided. Haven't decided share IPD to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jieqing Wan principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atheroscleroses, Cerebral and Intracranial Atherosclerosis, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yameng Sun (+86-13621603083, Frank_sym@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614972, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.