Symptomatic Intracranial Atherosclerotic StenosisPhase 3DESIASNCT07197970
Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis
A Phase 3 study testing NxiDIME™ Intracranial Drug-Eluting Stent System and NOVA DES Intracranial Drug-Eluting Stent in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Intracranial Atherosclerotic Stenosis
- What is being tested?
- NxiDIME™ Intracranial Drug-Eluting Stent System and NOVA DES Intracranial Drug-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 15 May 2027
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and ≤ 80 years old, regardless of gender.
- Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy;
- Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score < 3; Hypoperfusion: 1. The cerebral blood flow (CBF) in the target artery territory decreases by > 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or 2. There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction);
- Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter <2.25 mm or 4.0 mm < target vessel diameter ≤5.5 mm or 15 mm < lesion length ≤40 mm, enroll in single-arm cohort study);
- mRS score ≤ 2;
- Patient or legal guardian voluntarily participates and signs the written ICF, with willingness to comply with protocol-specified examinations and follow-up.
Who cannot join
- History of prior stent implantation or surgical treatment at the target lesion;
- Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;
- Major surgical procedure within 30 days prior to the procedure;
- Acute ischemic stroke within 14 days prior to the procedure;
- Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial/extracranial vascular stenosis ≥70% requiring intervention;
- Severe calcification, significant stenosis, or tortuosity of the target vessel precluding device deployment as assessed by investigators;
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- Intracranial tumor, arteriovenous malformation, or tandem aneurysms proximal/distal to the target lesion;
- Non-atherosclerotic stenosis etiology (e.g., arterial dissection, moyamoya disease, vasculitis);
- Cardiac thromboembolic sources (e.g., atrial fibrillation, left ventricular thrombus, myocardial infarction within 6 weeks);
- Uncontrolled hypertension (persistent systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg);
- Contraindications to antiplatelet/anticoagulant therapy, coagulopathy or bleeding diathesis precluding intervention per investigator judgment;
- Severe comorbidities: cardiac failure (New York Heart Association (NYHA) Class III-IV), respiratory/renal failure (serum creatinine >3.0 mg/dL (264 μmol/L)), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than 3 times the upper limit of the normal value), active malignancy;
- Hypersensitivity to rapamycin, polylactic-co-glycolic acid, nitinol, platinum-tungsten, anesthetics, or contrast agents;
- Life expectancy <1 year;
- Pregnancy, lactation, or planned pregnancy within 1 year;
- Concurrent participation in other clinical trials without completing primary endpoint follow-up;
- Cognitive impairment or psychiatric disorders compromising protocol compliance; other exclusionary conditions per investigator discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
A prospective, multi-center, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the NxiDIME™ Intracranial Drug-Eluting Stent System in the treatment of symptomatic intracranial atherosclerotic stenosis lesions
Beijing, Beijing Municipality, 100000
Ming Yang, Ph.D, 13331060083, wireyang20@163.com
About this study
Official title: A Prospective, Multi-center, Randomized Controlled, Clinical Trial to Evaluate the Safety and Efficacy of NxiDIME™ Intracranial Drug-eluting Self-expanding Stent System
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subjects meeting all inclusion criteria and without any exclusion criteria will enter the investigation after providing written informed consent via ethics committee-approved informed consent forms (ICFs). The randomized controlled study plans to enroll 224 patients, stratified by intracranial lesion location (anterior/posterior circulation), through a centralized randomization system. The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting Stent System (RICOTON Technology Co., Ltd.), while the control group will receive the NOVADES® Intracranial Drug-Eluting Stent System.
All subjects underwent follow-up visits on the day of the procedure, within 7 days postoperatively or prior to discharge, and at 30 days, 6 months, and 12 months postoperatively.
- Being tested
- NxiDIME™ Intracranial Drug-Eluting Stent System, NOVA DES Intracranial Drug-Eluting Stent
- Keywords
- symptomatic intracranial atherosclerotic stenosis, Drug-Eluting Stent, strok
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NxiDIME™ Intracranial Drug-Eluting Stent SystemDevice
The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System (RICOTON Technology Co., Ltd.)
NOVA DES Intracranial Drug-Eluting StentDevice
The experimental group will receive the NOVA DES Intracranial Drug-Eluting balloon-expandable stent System
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Endovascular angioplasty with NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System Receives: Device: NxiDIME™ Intracranial Drug-Eluting Stent System |
| Controal group | Active comparator | Endovascular angioplasty with NOVA Intracranial Drug-Eluting Balloon-expandable Stent Receives: Device: NOVA DES Intracranial Drug-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month incidence rate of in-stent restenosis
In-stent restenosis is defined as luminal stenosis >50% within the stent or adjacent 5-mm segments, accompanied by late lumen loss >20% relative to immediate post-procedural measurements by follow-up DSA.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start15 May 2025
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Intracranial Atherosclerotic StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the NxiDIME™ Intracranial drug-eluting self-expanding stent against the NOVA DES® Intracranial Drug-Eluting balloon-expandable stents for patients with symptomatic intracranial atherosclerotic stenosis.
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197970
- Sponsor's protocol ID
- QX2025-002-01
- Acronym
- DESIAS
- Status last verified
- Apr 2025
- First submitted
- 25 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled, Clinical Trial to Evaluate the Safety and Efficacy of NxiDIME™ Intracranial Drug-eluting Self-expanding Stent System
- ClinicalTrials.gov ID
- NCT07197970
- Acronym / sponsor ID
- DESIAS / QX2025-002-01
- Keywords
- symptomatic intracranial atherosclerotic stenosis, Drug-Eluting Stent, strok
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 30 Sep 2025 (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.
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subjects meeting all inclusion criteria and without any exclusion criteria will enter the investigation after providing written informed consent via ethics committee-approved informed consent forms (ICFs). The randomized controlled study plans to enroll 224 patients, stratified by intracranial lesion location (anterior/posterior circulation), through a centralized randomization system. The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting Stent System (RICOTON Technology Co., Ltd.), while the control group will receive the NOVADES® Intracranial Drug-Eluting Stent System.
All subjects underwent follow-up visits on the day of the procedure, within 7 days postoperatively or prior to discharge, and at 30 days, 6 months, and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the NxiDIME™ Intracranial drug-eluting self-expanding stent against the NOVA DES® Intracranial Drug-Eluting balloon-expandable stents for patients with symptomatic intracranial atherosclerotic stenosis.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: NxiDIME™ Intracranial Drug-Eluting Stent SystemEndovascular angioplasty with NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System |
| Controal group | Active comparator | Device: NOVA DES Intracranial Drug-Eluting StentEndovascular angioplasty with NOVA Intracranial Drug-Eluting Balloon-expandable Stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old and ≤ 80 years old, regardless of gender.
- Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy;
- Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score < 3; Hypoperfusion: 1. The cerebral blood flow (CBF) in the target artery territory decreases by > 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or 2. There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction);
- Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter <2.25 mm or 4.0 mm < target vessel diameter ≤5.5 mm or 15 mm < lesion length ≤40 mm, enroll in single-arm cohort study);
- mRS score ≤ 2;
Key exclusion criteria (17 listed)
- History of prior stent implantation or surgical treatment at the target lesion;
- Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;
- Major surgical procedure within 30 days prior to the procedure;
- Acute ischemic stroke within 14 days prior to the procedure;
- Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial/extracranial vascular stenosis ≥70% requiring intervention;
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 |
|---|---|---|
| NxiDIME™ Intracranial Drug-Eluting Stent SystemThe experimental group will receive the NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System (RICOTON Technology Co., Ltd.) | Device | Experimental group |
| NOVA DES Intracranial Drug-Eluting StentThe experimental group will receive the NOVA DES Intracranial Drug-Eluting balloon-expandable stent System | Device | Controal group |
Primary outcome
12-month incidence rate of in-stent restenosis
Time frame: 12-month
In-stent restenosis is defined as luminal stenosis >50% within the stent or adjacent 5-mm segments, accompanied by late lumen loss >20% relative to immediate post-procedural measurements by follow-up DSA.
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 30 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NxiDIME™ Intracranial Drug-Eluting Stent System and NOVA DES Intracranial Drug-Eluting Stent in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
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 17 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Feng Gao, Ph.D (13581936066, geofengletter@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month incidence rate of in-stent restenosis (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.