Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke

Ischemic Stroke Clinical Trial

— INSIS  

Official title:

Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke: an Open-label, Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063630
• Other study ID #: CanTho S.I.S Hospital
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 24, 2022

Study information

• Verified date: September 2021
• Source: Can Tho Stroke International Services Hospital
• Contact: Cuong Tran Chi, Doctor
• Phone: +84886559911
• Email: drcuongtran[@]dotquy.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In non-acute symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there is no evidence from randomized controlled trials evaluating the efficacy of this treatment after the Wingspan Stent System Post Market Surveillance (WEAVE) and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) trial compared with medical treatment alone. This trial was to investigate whether medical treatment plus intracranial stenting would prevent the recurrent ischemic stroke in the territory of the symptomatic intracranial artery during 1-year follow-up.

Description:

In symptomatic ischemic stroke due to intracranial large severe stenosis or occlusive artery, the choice for treatment has remained controversial after results of the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial because it demonstrated that the efficacy of medical treatment was superior to intracranial stenting in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of intracranial stenting in the ischemic stroke treatment and recovery time for a long time because of the unproper patient selection of this trial such as no evidence of medical failure, intracranial stenting earlier than 7 days after the stroke and intracranial stenting in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about intracranial stenting, WEAVE trial, reported not only 97.4% patients with no complication at 72 hours, but also a relatively low 8.5% recurrent stroke and death rate during 1 year in the WOVEN study. In case of the symptomatic stenosis greater than 70%, the probability of recurrent stroke and transient ischemic attack in the territory of the symptomatic stenotic artery in 1 year was 23% and 14%, respectively, despite treatment with antithrombotic therapy and standard management of vascular risk. Given a lot of patients with symptomatic ischemic stroke who have some adjustable indications for intracranial stenting deployment in the world and a paucity of evidence from randomized trials, the purpose of this trial was to compare this treatment versus medical one in the intracranial large severe stenosis or occlusive artery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 24, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Evidence of intracranial large severe stenosis or occlusive artery in angiography.
• Absence of intracranial hemorrhage.
• Premorbid mRS score is = 3.
• Recurrent stroke in the target territory during the medical treatment for ischemic stroke prevention.

Exclusion Criteria:

• Tandem lesion.
• Loss to follow-up after discharge.
• A severe or fatal combined illness before acute ischemic stroke.
• Progressive neurologic deficit within 7 days after acute ischemic stroke.
• Large middle cerebral artery infarct within 30 days after acute ischemic stroke.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Cerebral Infarction
• Intracranial Arterial Diseases
• Intracranial Arteriosclerosis
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Medical treatment plus intracranial stenting
This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.

Drug:
• Medical treatment alone
This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.

Locations

Country	Name	City	State
Vietnam	Can Tho SIS Hospital	C?n Tho

Sponsors (1)

Lead Sponsor	Collaborator
Can Tho Stroke International Services Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (5)

Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, Song SS, Yu W; WEAVE Trial Sites and Interventionalists. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996. — View Citation

Alexander MJ, Zauner A, Gupta R, Alshekhlee A, Fraser JF, Toth G, Given C, Mackenzie L, Kott B, Hassan AE, Shownkeen H, Baxter BW, Callison RC, Yu W. The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes. J Neurointerv Surg. 2021 Apr;13(4):307-310. doi: 10.1136/neurintsurg-2020-016208. Epub 2020 Jun 19. — View Citation

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

Markus HS, Larsson SC, Dennis J, Kuker W, Schulz UG, Ford I, Clifton A, Rothwell PM. Vertebral artery stenting to prevent recurrent stroke in symptomatic vertebral artery stenosis: the VIST RCT. Health Technol Assess. 2019 Aug;23(41):1-30. doi: 10.3310/hta23410. — View Citation

Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.	Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.	During 1 year after randomization.
Secondary	Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.	Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.	During 1 year after randomization.
Secondary	Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery.	Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery was accessed by modified Rankin Score (mRS).	During 3 months after randomization..