Endovascular Recanalization and Standard Medical Management for Symptomatic Nonacute Intracranial Artery Occlusion Trial

NCT ID: NCT04864691

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-10-31

Brief Summary

Background The management of patients with symptomatic nonacute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. Some small-sample clinical studies have also discussed endovascular recanalization for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The aim of our present study was to evaluate the technical feasibility and safety of endovascular recanalization for sNA-ICAO.

Methods and analysis: Our group is currently undertaking a multisite, nonrandomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between May 1, 2020, and April 30, 2023. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is the composite of stroke/TIA within 2 years following enrollment and stroke/TIA ipsilateral to the target vessel. The secondary efficacy outcome includes the following two parts: 1) the incidence of stroke/TIA ipsilateral to the target vessel within 30 days and 90 days in both groups; 2) the all-cause mortality, mRS score, NIHSS score and cognitive function at 30 days, 90 days, 8 months, 12 months and 24 months for both groups, including the MRI, CTA/MRA, CTP or MRP results in patients with internal carotid artery or middle cerebral artery occlusion as well as CTA in patients with basilar or vertebral artery occlusion at 90 days, 12 months and 24 months. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat.

Ethics and dissemination This study protocol was reviewed and approved primarily by Beijing Tiantan Hospital, the Capital Medical University Medical Ethics Committee, and the institutional review boards of all partner sites. The study is being externally monitored, and the results will be published in open-access peer-reviewed scientific journals and presented to academic and policy stakeholders.

Conditions

Intracranial Artery Occlusion With Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

endovascular recanalization plus standard medical treatment

patients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure

Group Type: EXPERIMENTAL

endovascular recanalization

Intervention Type: BIOLOGICAL

to recanalize the occlusion cerebral artery with intravascular intervention

standard medical treatment

Patients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure)

Group Type: ACTIVE_COMPARATOR

endovascular recanalization

Intervention Type: BIOLOGICAL

to recanalize the occlusion cerebral artery with intravascular intervention

Interventions

endovascular recanalization

to recanalize the occlusion cerebral artery with intravascular intervention

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient age ≥ 18 years old and life expectancy of 5 years or more.

2. Symptomatic sNA-ICAO defined as:diagnosed by CTA or MRA and confirmed by angiography; Vascular occlusion time more than 24 hours;TIA or ischemic stroke (confirmed by CT or MRI) related to the LCAO despite SMT < 90 days prior to enrollment.

3. Modified Rankin scale score 0-2 at the time of informed consent.

4. More than one risk factor for atherosclerosis.

5. For patients with ICA or MCA M1 segment occlusion, ipsilateral hypoperfusion confirmed by CTP or MRI perfusion imaging prior to enrollment and analysis by the RAPID system.

6. For patients with intracranial segment occlusion of the vertebral artery, severe stenosis or occlusion of the contralateral vertebral artery.

7. Among women, no childbearing potential; or if a woman with childbearing potential, a negative pregnancy test result prior to randomization.

8. Agreement of the patient to comply with all protocol-specified follow-up appointments.

9. Signature by a patient of a consent form that has been approved by the local governing institutional review board (IRB)/medical ethics committee (MEC) of the respective clinical site.

Exclusion Criteria

1. Intolerance or allergic reaction to a study medication without a suitable management alternative.

2. No atherosclerotic intracranial vasculopathies, such as dissection, moyamoya disease and vasculitis.

3. Concomitant intracranial aneurysms or any bleeding disorder.

4. Life expectancy <1 year due to other medical conditions.

5. Large infarction core, defined as an ASPECTS < 6 in anterior circulation and pc-ASPECTS < 6 points in posterior circulation.

6. For patients with MCA M1 segment occlusion, concomitant ≥50% stenosis of the proximal internal carotid artery or other intracranial arteries.

7. For patients with intracranial segment occlusion of the vertebral artery, continuance of the occluded vertebral artery to the posterior inferior cerebellar artery with no stump.

8. Incomplete clinical and imaging data.

9. Coexistent cardioembolic source (e.g., atrial fibrillation, mitral stenosis, prosthetic valve, MI within six weeks, intracardiac clot, ventricular aneurysm and bacterial endocarditis).

10. Occlusive lesions with severe calcification.

11. Platelet count <100,000/ml or history of heparin-induced thrombocytopenia.

12. Left ventricular ejection fraction <30% or admission for heart failure in the prior 6 months.

13. Extreme morbid obesity that would compromise patient safety during the procedure or the periprocedural period.

14. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not or cannot be revascularized.

15. Anticoagulation with Marcumar, warfarin or direct thrombin inhibitors or anti-XA drugs.

16. Chronic atrial fibrillation.

17. Any history of atrial fibrillation or paroxysmal atrial fibrillation in the past 6 months that is considered to require long-term anticoagulant therapy.

18. Other high-risk cardiogenic embolisms, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcified aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus or any intracardiac mass or known paradoxical embolism of unrepaired PFO.

19. Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).

20. Any major surgery, major trauma, revascularization procedure or acute coronary syndrome within the past 1 month.

21. serum creatinine >2.5 mg/dl or estimated GFR <30 cc/min.

22. Major surgery planned within 3 months after enrollment.

23. Currently listed or being evaluated for major organ transplantation (i.e., heart, lung, liver and kidney).

24. Participation in other trials and may affect the results of this study.

25. Inability to understand and cooperate with research procedures or provide informed consent.

26. Endarterectomy, bypass or stent implantation performed on the proximal end of the occlusion vessel.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Feng Gao

OTHER

Sponsor Role: lead

Responsible Party

Feng Gao

Department of Interventional Neurology, Beijing Tiantan Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

feng feng, professor

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Beijing You 'anmen Hospital

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Liangxiang Hospital

Beijing, Beijing Municipality, China

Handan Central Hospital

Handan, Hebei, China

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, China

ORDOS Central Hospital

Ordos, Inner Mongolia, China

TongLiao City Hospital

Tongliao, Inner Mongolia, China

Jingjiang people's Hospital

Jingjiang, Jiangsu, China

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Tai'an Hospital of Traditional Chinese Medicine

Tai’an, Shandong, China

Tong Ren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Taiyuan Central Hospital

Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Taizhou first people's Hospital

Taizhou, Zhejiang, China

Countries

China

References

Zhang H, Han J, Sun X, Miao Z, Guo X, Xu G, Sun Y, Wen C, Wang C, Wu Y, Xu Y, Jiang Y, Zhang S, Liu C, Li D, Liu Y, Xu C, Gao F. Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study. Front Neurol. 2021 Sep 28;12:729534. doi: 10.3389/fneur.2021.729534. eCollection 2021.

Reference Type: DERIVED

PMID: 34650509 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018AAA0102600

Identifier Type: -

Identifier Source: org_study_id