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A multicenter randomized controlled trial comparing the effectiveness of EC-IC bypass and percutaneous transluminal angioplasty in preventing stroke in patients with middle cerebral artery stenosis/occlusion

A multicenter randomized controlled trial comparing the effectiveness of EC-IC bypass and percutaneous transluminal angioplasty in preventing stroke in patients with middle cerebral artery stenosis/occlusion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038680
Enrollment
Unknown
Registered
2020-09-28
Start date
2020-11-02
Completion date
Unknown
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

middle cerebral artery stenosis/occlusion

Interventions

EC-IC bypass:low-flow STA-MCA bypass
PTAS:PTAS

Sponsors

3rd Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. In the last 6 months, under standard antiplatelet or anticoagulation treatment, symptoms of cerebral ischemia still occur, including transient melancholia, TIA attacks, and small strokes (persistent neurological impairment with NIHSS = 50%, < 100% (determined by WAIDS method); 6. SPECT or CTP showed that the MTT ratio of the ipsilateral-to-contralateral frontal posterior inferior gyrus is greater than 1.13 (refer to the ratio of the affected and contralateral Oxygen extraction fraction in the COSS enrollment criteria); 7. DSA showed the presence of the superficial temporal artery on the affected side.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhage or hemorrhagic cerebral infarction occurred in the past 6 months, or a large area of cerebral infarction with a diameter of more than 5 mm in a stenosis-related area, or severe stroke (NIHSS score >= 9 points); 2. Intracranial arterial stenosis for special reasons: for example, confirmed moyamoya disease, moyamoya syndrome, cerebral arteritis (infectious arteritis, systemic vasculitis), muscular fiber dysplasia, cerebral artery window deformity, radiation injury, arterial dissection Patient 3. accompanied by intracranial tumors, aneurysms and cerebral arteriovenous malformations; 4. Patients cannot receive aspirin, clopidogrel, and are allergic to heparin or iodine-containing contrast agents; 5. Renal insufficiency, or combined with severe heart, lung, liver and other organ dysfunction; 6. Positive pregnancy test for women of childbearing age; 7. hemoglobin 1.5; 9. non-iatrogenic uncorrectable bleeding tendency; 10. A history of major surgery within 30 days; 11. Poor general condition, intolerance of general anesthesia surgery, or 12. life expectancy < 5 years.

Design outcomes

Primary

MeasureTime frame
Transient ischemic attack;Infarction;

Secondary

MeasureTime frame
Cerebral hemorrhage;Cerebral blood perfusion;STA diameter;Diameter in stenosis site of MCA;Hospital costs;

Countries

China

Contacts

Public ContactChen Chuan

3rd Affiliated Hospital of Sun Yat-sen University

speed4@126.com+86 13826472625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026