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

NCT05719883 | Completed

• 1 other identifier: QX2022-021-02
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intracranial Arteriosclerosis; Stroke (CVA) or TIA

Keywords

Intracranial Atherosclerotic stenosis; Drug-eluting stent; Ischemia stroke

Outcome Measures

Primary Outcomes (1)

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

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

  12 months after procedure

Secondary Outcomes (12)

• Implantation success rate

  During the procedure

• Technical success rate

  During the procedure

• Clinical success rate

  12 months after procedure

• Stroke or death within 30 days after procedure

  within 30 days after procedure

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

  within 30 days after procedure

Other Outcomes (3)

• Complications of stent implantation procedure

  12 months after procedure

• Stroke

  12 months after procedure

• adverse events (AE) and serious adverse events (SAE)

  12 months after procedure

Study Arms (2)

Maurora® Sirolimus Eluting Stent System

EXPERIMENTAL

Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys.

Device: Maurora® Sirolimus Eluting Stent System

APOLLO™ Intracranial Stent System

ACTIVE COMPARATOR

Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system.

Device: APOLLO™ Intracranial Stent System

Interventions

Maurora® Sirolimus Eluting Stent System DEVICE

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.

Also known as: Maurora

Maurora® Sirolimus Eluting Stent System

APOLLO™ Intracranial Stent System DEVICE

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.

Also known as: APOLLO

APOLLO™ Intracranial Stent System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Alain Medical (Beijing) Co., Ltd.: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (6)

• 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.

  PMID: 31248666 BACKGROUND

• 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.

  PMID: 30871944 BACKGROUND

• 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.

  PMID: 15800226 BACKGROUND

• 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.

  PMID: 21899409 BACKGROUND

• 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.

  PMID: 23277374 BACKGROUND

• 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.

  PMID: 23963335 BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ning Ma, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: February 20, 2023
• Primary Completion: April 30, 2025
• Study Completion: May 15, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (1)