PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Harbin Medical University

Status

Completed

Conditions

Intravascular Imaging Device

Coronary Artery Disease

Treatments

Diagnostic Test: Intravascular ultrasound

Diagnostic Test: Optical coherence tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT05596279

VP-3003-1901

Details and patient eligibility

About

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were all recommended for percutaneous coronary intervention (PCI) optimization in the latest guidelines, however, which imaging modality was more suitable as either a diagnostic or guidance tool was still unknown. Recently, a novel, well-designed hybrid imaging system was approved for clinical use, allowing the accurate co-registration of two imaging modalities and immediate, simultaneous image review. For testing each modality in the hybrid imaging system, the investigators conducted this prospective, multicentre, non-inferiority trial. In this study, all participants achieved hybrid IVUS-OCT imaging after stenting, at meanwhile, patients randomly assigned to the IVUS arm were performed control IVUS (OptiCross, Boston Scientific, Natick, MA), and patients randomly assigned to the OCT arm were performed control OCT (C7 Dragonfly Duo, St. Jude Medical, St. Paul, MN). In this study, the investigators evaluated the non-inferiority of standalone IVUS versus control IVUS or standalone OCT versus control OCT in clinical feasibility using clear stent capture rate (CSCR) and safety using perioperative device-related adverse cardiovascular events.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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