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Optical Coherence Tomography Guidance versus Angiography in Carotid Angioplasty and Stenting: a prospective, randomized and monocenter trial

Optical Coherence Tomography Guidance versus Angiography in Carotid Angioplasty and Stenting: a prospective, randomized and monocenter trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065277
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

carotid artery stenosis

Interventions

OCT guidance:Oct-guided reprocessing after carotid artery stenting
DSA guidance:DSA-guided reprocessing after carotid artery stenting

Sponsors

Municipal Central Hospital of Dalian University of Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) aged 18 years and above; 2) asymptomatic internal carotid artery (ICA) stenosis >70% (confirmed by DSA/CTA/ carotid ultrasound); 3) symptomatic internal carotid artery stenosis >50% (confirmed by DSA/CTA/ carotid ultrasound), which was defined as cerebral infarction or transient ischemic attacks (TIA) or amaurosis fuwai caused by carotid artery stenosis within 6 months; 4) Informed consent was obtained from patients or their legal representatives

Exclusion criteria

Exclusion criteria: 1) intracranial hemorrhage confirmed by head CT or MRI; 2) The infarct size was more than one third of the MCA territory as confirmed by head CT or MRI 3) mRS Score >=3 before onset; 4) pregnant or lactating women; 5) contrast media or Nitinol allergy; 6) participating in other clinical trials; 7) systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg and uncontrolled by antihypertensive drugs; 8) genetic or acquired bleeding constitution, anticoagulant factor deficiency; 9) blood glucose 400mg/dl (22.2mmol/L), platelet <50*109/L, or hematocrit <25%; 10) Failure of the device to reach the target vessel if the artery is severely tortuosity; 11) life expectancy <1 year; 12) patients who could not complete 1-year follow-up (e.g., patients without fixed residence, overseas patients, etc.); 13) patients presenting with acute ischemic cerebral infarction within 48 hours after percutaneous coronary or cerebrovascular intervention or major surgery (if more than 48 hours, patients were eligible); 14) with a definite history of cerebral vasculitis; 15) patients with pre-existing neurological or mental disorders that may affect the assessment of the disease;

Design outcomes

Primary

MeasureTime frame
Minimum stent expansion;Minimum sectional area in the stent;

Countries

China

Contacts

Public ContactZhongjun Chen

Municipal Central of Dalian University of Technology

chenjiajin1983729@163.com+86 18841180447

Outcome results

None listed

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