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

September 23, 2024 updated by: RenJi Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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%.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. 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).
  3. 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).
  4. 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.
  5. Baseline mRS score ≤3.
  6. Patient or guardian signs informed consent.

Exclusion Criteria:

  1. 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.
  2. Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
  3. Gastrointestinal disease with active bleeding.
  4. Myocardial infarction or massive cerebral infarction within 2 weeks.
  5. Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
  6. Life expectancy <12 months.
  7. According to the judgement of the investigator, other situations that are not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
balloon-expandable drug-eluting stent
Patients were treated with balloon-expandable drug-eluting stent.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after implantation
Periprocedural events
Time Frame: within 30 days after implantation
Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death.
within 30 days after implantation
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.
12 months after implantation
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%.
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
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.
Every year after implantation during 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-5 years after implantation
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.
2-5 years after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Jieqing Wan, RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-188-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Haven't decided share IPD to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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