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

NCT04864691 | Completed Early Phase 1 Results DMC

• 1 other identifier: 2018AAA0102600
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 15

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

Keywords

standard medical therapy; symptomatic non-acute intracranial artery occlusion; endovascular recanalization

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The primary outcome was a composite of any stroke or death within 30 days after enrollment or ischemic stroke in the territory of the qualifying artery from 30 days to 1 year after enrollment.

  One year

Secondary Outcomes (2)

• Incidence of Stroke/ TIA Ipsilateral to the Target Vessel

  within 30 days and 90 days in both groups

• All-cause Mortality, mRS Score, NIHSS Score and Cognitive Function

  t 30 days, 90 days, 8 months, 12 months and 24 months for both groups

Study Arms (2)

endovascular recanalization plus standard medical treatment

EXPERIMENTAL

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

Biological: endovascular recanalization

standard medical treatment

ACTIVE COMPARATOR

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)

Biological: endovascular recanalization

Interventions

endovascular recanalization BIOLOGICAL

to recanalize the occlusion cerebral artery with intravascular intervention

endovascular recanalization plus standard medical treatment; standard medical treatment

Eligibility Criteria

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

You may qualify if:

• Patient age ≥ 18 years old and life expectancy of 5 years or more.
• 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.
• Modified Rankin scale score 0-2 at the time of informed consent.
• More than one risk factor for atherosclerosis.
• 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.
• For patients with intracranial segment occlusion of the vertebral artery, severe stenosis or occlusion of the contralateral vertebral artery.
• Among women, no childbearing potential; or if a woman with childbearing potential, a negative pregnancy test result prior to randomization.
• Agreement of the patient to comply with all protocol-specified follow-up appointments.
• 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.

You may not qualify if:

• Intolerance or allergic reaction to a study medication without a suitable management alternative.
• No atherosclerotic intracranial vasculopathies, such as dissection, moyamoya disease and vasculitis.
• Concomitant intracranial aneurysms or any bleeding disorder.
• Life expectancy \<1 year due to other medical conditions.
• Large infarction core, defined as an ASPECTS \< 6 in anterior circulation and pc-ASPECTS \< 6 points in posterior circulation.
• For patients with MCA M1 segment occlusion, concomitant ≥50% stenosis of the proximal internal carotid artery or other intracranial arteries.
• 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.
• Incomplete clinical and imaging data.
• Coexistent cardioembolic source (e.g., atrial fibrillation, mitral stenosis, prosthetic valve, MI within six weeks, intracardiac clot, ventricular aneurysm and bacterial endocarditis).
• Occlusive lesions with severe calcification.
• Platelet count \<100,000/ml or history of heparin-induced thrombocytopenia.
• Left ventricular ejection fraction \<30% or admission for heart failure in the prior 6 months.
• Extreme morbid obesity that would compromise patient safety during the procedure or the periprocedural period.
• Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not or cannot be revascularized.
• Anticoagulation with Marcumar, warfarin or direct thrombin inhibitors or anti-XA drugs.

Sponsors & Collaborators

• Feng Gao: lead

Study Sites (15)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Beijing You 'anmen Hospital

Beijing, Beijing Municipality, 100054, China

Location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Liangxiang Hospital

Beijing, Beijing Municipality, 102401, China

Location

Handan Central Hospital

Handan, Hebei, 130403, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, 050055, China

Location

ORDOS Central Hospital

Ordos, Inner Mongolia, 150603, China

Location

TongLiao City Hospital

Tongliao, Inner Mongolia, 028000, China

Location

Jingjiang people's Hospital

Jingjiang, Jiangsu, 214500, China

Location

Dalian Municipal Central Hospital

Dalian, Liaoning, 116033, China

Location

Tai'an Hospital of Traditional Chinese Medicine

Tai’an, Shandong, 271000, China

Location

Tong Ren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China

Location

Taiyuan Central Hospital

Taiyuan, Shanxi, 030009, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Taizhou first people's Hospital

Taizhou, Zhejiang, 318020, China

Location

Related Publications (1)

• 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.

  PMID: 34650509 DERIVED

Results Point of Contact

• Title: Feng Gao
• Organization: Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

gaofengletter@sina.com

13581936066

Study Officials

• feng feng, professor

  Beijing Tiantan Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Interventional Neurology, Beijing Tiantan Hospital

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 29, 2021
• Study Start: January 1, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (15)