Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion: the CMOSS-2 Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The CMOSS-2 trial is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit symptomatic chronic occlusion of the middle cerebral artery in patients with severe hemodynamic insufficiency. Only high-volume center with a proven track record will be included. Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus bypass surgery. Primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age of 18-65 years;

• Confirmed as chronic occlusion of unilateral middle cerebral artery (MCA) by digital subtraction angiography (DSA) or computed tomography angiography (CTA). Other cerebral artery stenosis should be less than 50%.

• CT perfusion demonstrates severe hemodynamic insufficiency in the territory of the qualifying MCA with MTT (symptomatic side) ≥ 6s or rCBF (symptomatic side/contralateral side) ≤ 0.8;

• mRS score is 0-2 points;

• A history of ischemic events (including\<1/2 cerebral infarction in the middle cerebral artery supply area, or transient ischemic attack \[TIA\]) related to the qualifying artery within 12 months ;

• The onset of acute stroke should be more than 1 month;

• CT or MRI excludes large cerebral infarction (infarction\>1/2 of the territory of the qualifying middle cerebral artery);

• Patients or their guardians voluntarily participate of the study and sign the consent form.

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University.
RECRUITING
Beijing
Contact Information
Primary
Yan Ma, MD
leavesyan@sina.com
13810669502
Backup
Tao Wang, MD
wangtao_dr@sina.com
18810302298
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2027-09
Participants
Target number of participants: 420
Treatments
Experimental: Surgery
The patients in the surgical group will be treated with direct extracranial to intracranial bypass surgery plus best medical treatment.
Active_comparator: Medical treatment
The patients will receive medical treatment alone according to the AHA/ASA Stroke and Transient Ischemic Attack (TIA) Stroke Prevention Guidelines (2021 edition).
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov