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Development and validation of a guidance system for intraoperative coronary artery occlusive lesions

Development and validation of a guidance system for intraoperative coronary artery occlusive lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108738
Enrollment
Unknown
Registered
2025-09-04
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

chronic total occlusion

Interventions

Test Group:Use a guidance system to guide the direction while performing routine PCI
Control Group:Perform PCI routinely

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. >=18 years old; 2. Patients diagnosed with coronary atherosclerotic heart disease (chronic total occlusion of the coronary arteries); 3. Complete CTA imaging data within 30 days before intervention; 4. Volunteer to participate in this study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity, the guardian must act on his/her behalf to participate in the informed consent process and sign the informed consent. If the subject is unable to read the informed consent form (e.g. illiterate subjects), a witness must witness the informed consent process and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Coronary artery images are obviously misplaced; 2. The standard deviation (SD value) of the CT value of the aortic root image is >30HU; 3. Image quality does not meet analysis needs; 4. Vulnerable groups other than the illiterate/elderly, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.

Design outcomes

Primary

MeasureTime frame
PCI-related complications;

Secondary

MeasureTime frame
Operation duration;proportion of contrast-induced nephropathy;radiation dose;contrast dose;

Countries

China

Contacts

Public ContactHe Huang

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

huanghe_76@163.com+86 139 5808 5799

Outcome results

None listed

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