Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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%.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Balloon-expandable drug-eluting stent
DeviceBalloon-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.
Treatment groups
520 Participants
are divided into 1 treatment groupGroup A: balloon-expandable drug-eluting stent1 intervention
Trial outcomes
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.
Time frame
12 months after implantationSecondary outcomes
1
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
Time frame
12 months after implantation2
Periprocedural events
Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death.
Time frame
within 30 days after implantation3
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.
Time frame
12 months after implantation4
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%.
Time frame
During the procedureOther outcomes
1
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.
Time frame
2-5 years after implantation2
Any cerebral events
Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery.
Time frame
2-5 years after implantationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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