Status:
COMPLETED
Endovascular Recanalization and Standard Medical Management for Symptomatic Nonacute Intracranial Artery Occlusion Trial
Lead Sponsor:
Feng Gao
Conditions:
Intracranial Artery Occlusion With Infarction
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 isch...
Eligibility Criteria
Inclusion
- inclusion criteria:
- 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.
- exclusion criteria:
- 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.
- Chronic atrial fibrillation.
- Any history of atrial fibrillation or paroxysmal atrial fibrillation in the past 6 months that is considered to require long-term anticoagulant therapy.
- 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.
- 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).
- Any major surgery, major trauma, revascularization procedure or acute coronary syndrome within the past 1 month.
- serum creatinine \>2.5 mg/dl or estimated GFR \<30 cc/min.
- Major surgery planned within 3 months after enrollment.
- Currently listed or being evaluated for major organ transplantation (i.e., heart, lung, liver and kidney).
- Participation in other trials and may affect the results of this study.
- Inability to understand and cooperate with research procedures or provide informed consent.
- Endarterectomy, bypass or stent implantation performed on the proximal end of the occlusion vessel.
Exclusion
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT04864691
Start Date
January 1 2020
End Date
October 31 2024
Last Update
February 18 2025
Active Locations (15)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
2
Beijing You 'anmen Hospital
Beijing, Beijing Municipality, China, 100054
3
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
4
Liangxiang Hospital
Beijing, Beijing Municipality, China, 102401