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A clinical trial to evaluate the imaging quality and safety of intravascular ultrasound optical coherence tomography synchronous imaging system/intravascular ultrasound optical coherence tomography synchronous imaging catheter

A clinical trial to evaluate the imaging quality and safety of intravascular ultrasound optical coherence tomography synchronous imaging system/intravascular ultrasound optical coherence tomography synchronous imaging catheter

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048013
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-01-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Coronary Heart Disease

Interventions

Case series:Nil

Sponsors

Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years old; 2. Able to understand the purpose of the trial, recognize the risks and benefits stated in the informed consent document, and voluntarily sign a written informed consent form; 3. PCI is required, a single stent is implanted in the target lesion, and another angiography is performed after the stent is implanted.

Exclusion criteria

Exclusion criteria: Subject related: 1. Women who are pregnant and cannot be ruled out for pregnancy; 2. Renal insufficiency (eGFR <30 ml/min/1.73 m2)*; 3. Cardiac insufficiency [LVEF <35% within 7 days (including 7 days) before surgery]; 4. Uncontrolled malignant arrhythmia, such as high-risk ventricular premature beats, ventricular tachycardia; 5. Hemorrhage tendency, active peptic ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within six months; 6. Contraindications of antiplatelet inhibitors and anticoagulants; 7. Known to be allergic to any component of drugs or research equipment necessary for operation: such as aspirin, clopidogrel, heparin, contrast media, ticagrelor, bivalirudin, stent metal materials Material; 8. Plan to perform PCI again within 48 hours to intervene in non-target vessels; 9. Other researchers believe that it is not suitable for inclusion. *: eGFR calculation formula (Cockcroft): eGFR=(140-age)×weight÷(72×Scr)×(0.85 female) Lesions related: 1. Reference lumen diameter <2.5 mm; 2. The target lesion is located in the graft vessel; 3. The target lesion is located in the left main trunk or the coronary artery opening is damaged; 4. The target vessel is severely calcified; 5. The target vessel is severely distorted; 6. The target lesion has more than one stent in series; 7. Subjects diagnosed with coronary artery spasm; 8. Restenosis in the stent; 9. For other reasons, the investigator believes that it is not suitable for intravascular imaging.

Design outcomes

Primary

MeasureTime frame
Clear Image Length;

Countries

China

Contacts

Public ContactYundai Chen

Chinese People's Liberation Army General Hospital

cyundai@vip.163.com+86 13311119778

Outcome results

None listed

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