PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Launched by HARBIN MEDICAL UNIVERSITY · Oct 25, 2022

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-75 years
• • Patients eligible for elective percutaneous coronary intervention
• • Understand and voluntarily sign the informed consent form
• Exclusion Criteria:
• The lesion-related exclusion criteria:
• • More than 1 stent was planned to deploy in culprit lesion
• • In-stent restenosis
• • Bifurcation lesion with proposed double stent implantation
• • The length of the reference vessel segment proximal or distal to the lesion was less than 5mm
• • The length of the implanted stent was larger than 33mm
• • The diameter of reference vessel was less than 2 mm or larger than 4 mm
• • Lesions were in left main or ostium of right coronary artery
• • The distance between either end of the lesion and the lateral branches larger than 2 mm in diameter was less than 5 mm
• • Angiography revealed thrombosis in culprit vessel
• • Severely calcified lesions or tortuous coronary arteries
• • Decreased blood flow (thrombolysis in myocardial infarction score ≤ 2)
• Patients-level exclusion criteria:
• • Breastfeeding or pregnant women, the subject (or his partner) who had a pregnancy plan during the trial or within 6 months after the end of the trial, and subject who did not agree to use contraception during the trial
• • Participants who had withdrawn from other clinical studies within 3 months or are participating in other clinical trials
• • Acute myocardial infarction occurred within one week prior to screening
• • Cardiac troponin I or cardiac troponin T levels exceed the upper limit of normal reference values within 72 hours of procedure and were of clinical significance
• • Renal insufficiency with creatinine \> 200μmol/L
• • Unsuitable for coronary artery bypass grafting (CABG)
• • Unsuitable for percutaneous coronary intervention;
• • Coronary spasm
• • Chronic total occlusion or subtotal occlusion
• • Severe hemodynamic disturbances or shock
• • History of CABG
• • Coagulation is abnormal and clinically significant
• • Severe heart failure (NYHA III, IV or Left ventricular ejection fraction \< 30%)
• • History of contrast allergy
• • Multi-vessel disease
• • Chemotherapy or planned chemotherapy
• • Investigators consider unsuitable for participants selected for this study