Intracranial ArteriosclerosisPhase 3NCT06925971

A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）

A Phase 3 study testing Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China), Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) and Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), in people with Intracranial Arteriosclerosis, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) Experimental Device B, a… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intracranial Arteriosclerosis
What is being tested?: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China), Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) and Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 279 participants
Where: 1 siteChina
Study dates: 15 Apr 2025to 1 Oct 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

1) Age 18-80 years old
2) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation
3) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
4) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA
5) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc
6) Subject and/or their legal representatives have the necessary mental capacity to understand the study purpose, agree to participate in the study, and sign the informed consent form

Who cannot join

1) mRS score≥3
2) Last ischemic stroke onset within 2 weeks
3) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.
4) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging
5) Hemorrhagic transformation in the territory of qualifying artery. Any parenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 days prior to procedure, or untreated chronic subdural hematoma(≥5 mm) according to preoperative imaging
6) Restenosis of qualifying lesion due to previous stenting.

Show all 25Show fewer

7) Qualifying lesion with severe calcification, extreme eccentricity, or extreme angulation which may affect stent deployment
8) Stenosis caused by non-atherosclerotic lesions, such as arterial dissection, moya-moya disease, or vasculitis
9) Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) in the distal or proximal to qualifying lesion
10) Concomitant multiple stenoses where qualifying lesions cannot be identified
11) Thrombus in the qualifying artery or complete occlusion of the qualifying artery
12) Severe calcification or tortuosity of qualifying artery to prevent stent from successful positioning and dilatation
13) Stenting in qualifying artery within one year
14) Concomitant aneurysms requiring treatment
15) Concomitant intracranial malignant tumors, intracranial arteriovenous malformations, intracranial venous sinus thrombosis, or other conditions inappropriate to participate in the study
16) Resistant hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg) despite use of medication
17) Acute myocardial infarction within 4 weeks prior to enrollment, or suspected cardiogenic embolism
18) Subjects with severe systemic diseases that cannot tolerate surgery, such as severe hepatic or renal impairment
19) Severe cognitive impairment or mental diseases
20) Contraindications to anticoagulants or antiplatelet drugs, such as anticoagulant or antiplatelet drug allergy, active bleeding, or coagulation disorder
21) Subjects with allergy or suspected allergy to anesthetics, contrast agents, rapamycin, polylactic acid, nickel-titanium alloy, cobalt-chromium alloy, stainless steel, and other stent materials, medications, and intraoperative medications
22) Women who are pregnant or breastfeeding
23) Subjects who are participating or planning to participate in any drug or device clinical study at the time of enrollment
24) Life expectancy ≤ 1 year
25) Other conditions inapplicable to participate in the study according to investigators' judgment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huina Lu contact

+8615901703529

HuiNa.Lu@microport.com

China1 site

Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
Jianmin Liu, Ph.D, liu118@vip.163.com

Other trials in China

About this study

Official title: A Prospective, Multi-center, Open-label, Controlled, Superiority, Randomized, Controlled Registration Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）

The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents:

Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) The device used in the control group is the Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), According to the inclusion and exclusion criteria specified in the protocol, approximately 249 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A, Experimental Group B, or the control group.

Considering the broader applicability of Experimental Device A and Experimental Device B compared to the control device, a specification subgroup is established. 20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.

Moreover, a subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration.

Overall, the total sample size for the study is 279 subjects. Clinical assessment will be conducted for all subjects before the procedure, during the procedure, at discharge, at 1 month (±7 days) follow-up, at 6 months (±30 days) follow-up, and at 12 months (±60 days) follow-up. At 12 months (±60 days), patients will undergo follow-up with DSA imaging. Unscheduled follow-ups may be performed as needed to record relevant indicators and evaluate the safety and efficacy of the two drug-eluting stents in the treatment of symptomatic cerebral artery atherosclerotic stenosis.

Conditions: Intracranial Arteriosclerosis
Being tested: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China), Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China), Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),
Medical subject headings: Intracranial Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)Device
Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)Device
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),Device
Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China)

Study groups in NCT06925971
Study group	Role	What they receive
Experimental Group A（a self-expanding rapamycin target-eluting stent ）	Experimental	Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A（total 249 subjects in randomization group in China） Receives: Device: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device B（a balloon-expandable rapamycin target-eluting stent）	Experimental	Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group B（total 249 subjects in randomization group in China） Receives: Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Control group（Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent）	Active comparator	Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to control group（total 249 subjects in randomization group in China） Receives: Device: Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),
Specification subgroup	Other	20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing. Receives: Device: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China); Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Overseas subgroup for Experimental Device B in Brazil	Other	A subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration Receives: Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)

What is being measured

The primary outcome is the main question the study is designed to answer.

In-stent restenosis (ISR) rate at 12 months post-procedure
ISR is defined as >50% stenosis within or adjacent (within 5 mm) to the stent as well as >20% absolute luminal loss according to the WASID method diagnosed by DSA
Measured: 12 months after surgery(±60days)

Secondary outcomes (7)

Technical success rate of stent implantation
defined as successful implantation into qualifying lesion as well as successful retraction of delivery system
Measured: Day 0（within 1hour after procedure）
Symptomatic ISR rate at 12 months post-procedure
ISR (ISR is defined as >50% stenosis within or adjacent (within 5 mm) to the stent as well as >20% absolute luminal loss according to the WASID method diagnosed by DSA) occurs with ischemic stroke or TIA from target lesion restenosis.
Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.
TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting<24 hours and no acute infarction.
Measured: 12 months after surgery(±60days)
Revascularization rate from qualifying artery at 12 months post-procedure
During follow-up, revascularization procedures (including interventional thrombectomy, angioplasty, vascular bypass, etc.) due to ischemic stroke or TIA from target lesions.
Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.
TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting<24 hours and no acute infarction.
Measured: During the days of follow-up(up to 12month ±60 days)
Modified Rankin Scale (mRS) score at 12 months post-procedure
Measured: 12 months after surgery(±60days)
Stroke or death related to qualifying lesion at 30 days, 6 months, and 12 months post-procedure
Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.
Measured: During the days of follow-up(up to 12month ±60 days)
Any stroke or death at 30 days, 6 months, and 12 months post-procedure
Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.
Measured: During the days of follow-up(up to 12month ±60 days)
Study device related serious adverse event rate during follow-up
Measured: During the days of follow-up(up to 12month ±60 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 20251 Oct 2027

First posted13 Apr 2025
Study start15 Apr 2025 (estimated)
Primary completion1 Oct 2027 (estimated)
Study completion1 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intracranial ArteriosclerosisStudies of the same condition, open and under way.
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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 279 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06925971
Sponsor's protocol ID: ALIM-2024-01-CIP-00
Status last verified: Apr 2025
First submitted: 27 Mar 2025
Last updated: 13 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Huina Lu

+8615901703529

HuiNa.Lu@microport.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Intracranial Arteriosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Open-label, Controlled, Superiority, Randomized, Controlled Registration Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）
ClinicalTrials.gov ID: NCT06925971
Acronym / sponsor ID: ALIM-2024-01-CIP-00
Conditions: Intracranial Arteriosclerosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 279 participants (estimated)
Lead sponsor: MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Apr 2025 (estimated)
Primary completion: 1 Oct 2027 (estimated)
Study completion: 1 Oct 2027 (estimated)
First posted: 13 Apr 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.

The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents:

Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) The device used in the control group is the Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), According to the inclusion and exclusion criteria specified in the protocol, approximately 249 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A, Experimental Group B, or the control group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Experimental Group A（a self-expanding rapamycin target-eluting stent ）	Experimental	Device: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A（total 249 subjects in randomization group in China）
Experimental Device B（a balloon-expandable rapamycin target-eluting stent）	Experimental	Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group B（total 249 subjects in randomization group in China）
Control group（Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent）	Active comparator	Device: Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to control group（total 249 subjects in randomization group in China）
Specification subgroup	Other	Device: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China), Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.
Overseas subgroup for Experimental Device B in Brazil	Other	Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)A subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

1) Age 18-80 years old
2) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation
3) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
4) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA
5) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc

Key exclusion criteria (25 listed)

1) mRS score≥3
2) Last ischemic stroke onset within 2 weeks
3) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.
4) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging
5) Hemorrhagic transformation in the territory of qualifying artery. Any parenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 days prior to procedure, or untreated chronic subdural hematoma(≥5 mm) according to preoperative imaging

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
Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)	Device	Experimental Group A（a self-expanding rapamycin target-eluting stent ）, Specification subgroup
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)	Device	Experimental Device B（a balloon-expandable rapamycin target-eluting stent）, Overseas subgroup for Experimental Device B in Brazil, Specification subgroup
Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China)	Device	Control group（Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent）

Primary outcome

In-stent restenosis (ISR) rate at 12 months post-procedure
Time frame: 12 months after surgery(±60days)
ISR is defined as >50% stenosis within or adjacent (within 5 mm) to the stent as well as >20% absolute luminal loss according to the WASID method diagnosed by DSA

7 secondary outcomes

Technical success rate of stent implantation
Time frame: Day 0（within 1hour after procedure）
Symptomatic ISR rate at 12 months post-procedure
Time frame: 12 months after surgery(±60days)
Revascularization rate from qualifying artery at 12 months post-procedure
Time frame: During the days of follow-up(up to 12month ±60 days)
Modified Rankin Scale (mRS) score at 12 months post-procedure
Time frame: 12 months after surgery(±60days)
Stroke or death related to qualifying lesion at 30 days, 6 months, and 12 months post-procedure
Time frame: During the days of follow-up(up to 12month ±60 days)
Any stroke or death at 30 days, 6 months, and 12 months post-procedure
Time frame: During the days of follow-up(up to 12month ±60 days)
Study device related serious adverse event rate during follow-up
Time frame: During the days of follow-up(up to 12month ±60 days)

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 13 Apr 2025.
Individual participant dataSharing planned: No

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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.

Huina Lu contact

+8615901703529

HuiNa.Lu@microport.com

Jianmin Liu principal investigator

Changhai Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 25 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 13 Apr 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 Huina Lu (+8615901703529, HuiNa.Lu@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent restenosis (ISR) rate at 12 months post-procedure (time frame: 12 months after surgery(±60days)). 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 NCT06925971.

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 13 Apr 2025.