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NCT05719883Completed

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

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)

Source: ClinicalTrials.gov · Last updated 26 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
156 (actual)
First submitted
31 Jan 2023
Start date
20 Feb 2023
Primary completion date
30 Apr 2025
Lead sponsor
Beijing Tiantan Hospital
Diseases
Stroke
NCT number
NCT05719883

What you commit to

  • Study type: Interventional
  • Participants enrolled: 156
  • From 20 Feb 2023 to the primary completion date, 30 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ischemic stroke within 2 weeks before the procedure;
  • Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery;
  • Participated in another investigational device or drug study within 30 days;

Other illness

  • Patients with stroke caused by perforating artery occlusion;
  • 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 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;

Lab values

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

Other

  • Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion;
  • Severe calcification at target lesion;
  • Intracranial tumor, aneurysm or intracranial arteriovenous malformation;
  • Life expectancy \<12 months;
  • Pregnant or lactating women, or planning for pregnancy;
  • According to the judgement of the investigator, other situations that are not suitable for enrollment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Tiantan Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.