Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Harbin Medical University
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Clear stent capture rate (CSCR)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Yu Bo
Director of Department of Cardiology
The Second Affiliated Hospital of Harbin Medical University
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
Outcomes
Primary Outcomes
Clear stent capture rate (CSCR)
Time Frame: During the procedure
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
Secondary Outcomes
- Detection rate of edge dissection, tissue prolapse and stent malapposition(During the procedure)
- Device success rate(During the procedure)
- Adverse procedure-related adverse cardiovascular events(Periprocedure)
- Proportion of patients with clear image length ≥ 24mm(During the procedure)