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Intracranial ArteriosclerosisMaurora ICASNCT05719883

Evaluating the Safety and Efficacy of the Maurora® DES in ICAS

A study testing Maurora® Sirolimus Eluting Stent System and APOLLO™ Intracranial Stent System in people with Intracranial Arteriosclerosis and Stroke (CVA) or TIA, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the RCT trial is to evaluate whether implantation of drug-eluting stent (DES) is more efficacious than bare metal stent (BMS) in prevention of in-stent restenosis (ISR) and improvement of outcomes for symptomatic intracranial atherosclerotic stenosis. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Maurora® Sirolimus Eluting Stent System and APOLLO™ Intracranial Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteChina
Study dates
20 Feb 2023to 15 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 from 18 to 80 years;
  • Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack [TIA] associated with intracranial atherosclerosis within 90 days of enrollment);
  • A major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery) with 70% to 99% stenosis on the angiography (According to WASID method);
  • The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter >1.5mm;
  • Only one stent planned for the target lesion;
  • A Modified Rankin Score of ≤ 3;
  • Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent.

Who cannot join

  • Ischemic stroke within 2 weeks before the procedure;
  • Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion;
  • Patients with stroke caused by perforating artery occlusion;
  • Severe calcification at target lesion;
  • Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks;
  • History of stenting or angioplasty of an intracranial artery;
Show all 17Show fewer
  • Intracranial tumor, aneurysm or intracranial arteriovenous malformation;
  • Intracranial artery stenosis caused by non-atherosclerotic lesions, including: moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, post-partum vascular disease, suspected vasospasm, suspicious embolism recanalization;
  • Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation);
  • Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure;
  • Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents;
  • Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit);
  • Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery;
  • Life expectancy <12 months;
  • Pregnant or lactating women, or planning for pregnancy;
  • Participated in another investigational device or drug study within 30 days;
  • According to the judgement of the investigator, other situations that are not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the Maurora® Sirolimus-Eluting Stent Versus the Apollo Stent in Intracranial Atherosclerotic Stenosis(Maurora ICAS Trial)

The purpose of the RCT trial is to evaluate whether implantation of drug-eluting stent (DES) is more efficacious than bare metal stent (BMS) in prevention of in-stent restenosis (ISR) and improvement of outcomes for symptomatic intracranial atherosclerotic stenosis. This trial is prospective, multi-center, randomized 1:1 single blind trial using Maurora sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 10 interventional neurology centers in China. The study is sponsored by Alain Medical (Beijing) Co., Ltd.

Read the detailed description

This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent versus bare metal stent (BMS) to treat intracranial stenosis of 70-99% degree. The primary endpoint is in-stent restenosis rate(ISR) within 12 months after revascularization procedure of the qualifying lesion during follow-up.

Being tested
Maurora® Sirolimus Eluting Stent System, APOLLO™ Intracranial Stent System
Keywords
Intracranial Atherosclerotic stenosis, Drug-eluting stent, Ischemia stroke
Medical subject headings
Intracranial Arteriosclerosis, Stroke, Ischemic Stroke

What participants receive

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

  • Maurora® Sirolimus Eluting Stent SystemDevice

    Also called Maurora

    The Maurora® for intracranial PTA treatment 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.

  • APOLLO™ Intracranial Stent SystemDevice

    Also called APOLLO

    The Apollo stent system comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.

Study groups in NCT05719883
Study groupRoleWhat they receive
Maurora® Sirolimus Eluting Stent SystemExperimentalDevice: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys.
Receives: Device: Maurora® Sirolimus Eluting Stent System
APOLLO™ Intracranial Stent SystemActive comparatorDevice: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system.
Receives: Device: APOLLO™ Intracranial Stent System

What is being measured

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

  1. In-stent restenosis rate(ISR) within 12 months after procedure

    Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure

    Measured: 12 months after procedure

Secondary outcomes (12)

  1. Implantation success rate

    Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system.

    Measured: During the procedure

  2. Technical success rate

    Technical 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

  3. Clinical success rate

    Clinical 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%, and free from major adverse event within 12 months after procedure.

    system with a residual stenosis of <30%

    Measured: 12 months after procedure

  4. Stroke or death within 30 days after procedure

    Any stroke included ischemic stroke or/and symptomatic brain hemorrhage and all-cause death.

    Measured: within 30 days after procedure

  5. Stroke in the target vessel territory or death within 30 days after procedure

    Death or any stroke events related to target vessel after revascularization.

    Measured: within 30 days after procedure

  6. Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure

    Any ischemic stroke events related to target vessel after revascularization.

    Measured: between 31 day to 1 year after procedure

  7. Ischemic stroke in other vessel territory between 31 day to 1 year after procedure

    Any ischemic stroke events unrelated to target vessel after revascularization.Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery.

    Measured: between 31 day to 1 year after procedure

  8. Any ischemic stroke between 31 day to 1 year after procedure

    Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery.

    Measured: between 31 day to 1 year after procedure

  9. Any subdural, epidural hemorrhage or a systemic hemorrhage between 31 day to 1 year after procedure

    Any subdural or epidural hemorrhage or a systemic hemorrhage is required hospitalization, blood transfusion, or surgery.

    Measured: between 31 day to 1 year after procedure

  10. Death between 31 day to 1 year after procedure

    All-cause death.

    Measured: between 31 day to 1 year after procedure

  11. Transient Ischemic Attack within 1 year after the procedure

    A transient ischemic attack (TIA) is a temporary period of symptoms similar to those of a stroke. A TIA usually lasts only a few minutes up to 24 hours and doesn't cause permanent damage.

    Measured: 1 year after the procedure

  12. Functional outcome measured by the modified Rankin Scale

    Focus on difference between 1 month and 12 months after procedure. 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 worse a outcome.

    Measured: 1 and 12 months after procedure

Timeline

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

  1. First posted9 Feb 2023
  2. Study start20 Feb 2023
  3. Primary completion30 Apr 2025
  4. Study completion15 May 2025

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05719883
Sponsor's protocol ID
QX2022-021-02
Acronym
Maurora ICAS
Status last verified
Jun 2025
First submitted
31 Jan 2023
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.

    PubMed 31248666

  • GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

    PubMed 30871944

  • Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.

    PubMed 15800226

  • Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.

    PubMed 21899409

  • Shin YS, Kim BM, Suh SH, Jeon P, Kim DJ, Kim DI, Kim BS, Kim KH, Heo JH, Nam HS, Kim YD. Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis. Neurosurgery. 2013 Apr;72(4):596-604; discussion 604. doi: 10.1227/NEU.0b013e3182846e09.

    PubMed 23277374

  • Jin M, Fu X, Wei Y, Du B, Xu XT, Jiang WJ. Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis. Stroke. 2013 Nov;44(11):2990-4. doi: 10.1161/STROKEAHA.113.001824. Epub 2013 Aug 20.

    PubMed 23963335

Questions about this trial

What is this clinical trial studying?

A study testing Maurora® Sirolimus Eluting Stent System and APOLLO™ Intracranial Stent System in people with Intracranial Arteriosclerosis and Stroke (CVA) or TIA, 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 7 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: finished, as of the sponsor's last update on 26 Jun 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent restenosis rate(ISR) within 12 months after procedure (time frame: 12 months after procedure). 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 NCT05719883, which also lists 6 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 Jun 2025.

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