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

Stroke (CVA) or TIA Clinical Trial

— Maurora ICAS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719883
• Other study ID #: QX2022-021-02
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Beijing Tiantan Hospital
• Contact: Baixue Jia, MD
• Phone: 15010125093
• Email: beckyberry[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 85 years;

2. Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack [TIA] associated with intracranial atherosclerosis within 90 days of enrollment);

3. 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);

4. The target lesion length =15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter >1.5mm;

5. Only one stent planned for the target lesion;

6. A Modified Rankin Score of = 3;

7. Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent.

Exclusion Criteria:

1. Ischemic stroke within 2 weeks before the procedure;

2. Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion;

3. Patients with stroke caused by perforating artery occlusion;

4. Severe calcification at target lesion;

5. Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks;

6. History of stenting or angioplasty of an intracranial artery;

7. Intracranial tumor, aneurysm or intracranial arteriovenous malformation;

8. 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;

9. Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation);

10. Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure;

11. Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents;

12. Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit);

13. Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery;

14. Life expectancy <12 months;

15. Pregnant or lactating women, or planning for pregnancy;

16. Participated in another investigational device or drug study within 30 days;

17. According to the judgement of the investigator, other situations that are not suitable for enrollment.

Related Conditions & MeSH terms

• Arteriosclerosis
• Intracranial Arteriosclerosis
• Stroke (CVA) or TIA

Intervention

Device:
• Maurora® Sirolimus Eluting Stent System
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 System
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Alain Medical (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Erratum In: N Engl J Med. 2012 Jul 5;367(1):93. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2020 Jul 4;396(10243):26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications of stent implantation procedure	Any complications including vascular complications of assess the intracranial arteries, Allergic reactions or hypersensitivity to agents or device in procedure, complications of intracranial arteries, infection, fever, bleeding and other events.	12 months after procedure
Other	Stroke		12 months after procedure
Other	adverse events (AE) and serious adverse events (SAE)		12 months after procedure
Primary	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	Implantation success rate	Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system.	During the procedure
Secondary	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%.	During the procedure
Secondary	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%	12 months after procedure
Secondary	Stroke or death within 30 days after procedure	Any stroke included ischemic stroke or/and symptomatic brain hemorrhage and all-cause death.	within 30 days after procedure
Secondary	Stroke in the target vessel territory or death within 30 days after procedure	Death or any stroke events related to target vessel after revascularization.	within 30 days after procedure
Secondary	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.	between 31 day to 1 year after procedure
Secondary	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.	between 31 day to 1 year after procedure
Secondary	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.	between 31 day to 1 year after procedure
Secondary	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.	between 31 day to 1 year after procedure
Secondary	Death between 31 day to 1 year after procedure	All-cause death.	between 31 day to 1 year after procedure
Secondary	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.	1 year after the procedure
Secondary	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.	1 and 12 months after procedure