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Evaluation of Safety and Efficacy of the Novel dual-sensor system in Coronary intervention

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ischemic heart disease
Date of first enrollment	28/01/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Flow of PCI Procedures The PCI procedures in this clinical trial shall follow the standardized steps described below. The operator requirements for PCI in this study are defined as follows The procedure must be performed by a board certified interventional cardiologist accredited by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT), with at least five years of independent PCI experience. 1. Preparation and Vascular Access The procedure is performed under standard sterile conditions. Under local anesthesia, arterial access is obtained via the radial, brachial, or femoral artery, and an arterial sheath is inserted. A venous line is secured as needed, and anticoagulation (unfractionated heparin) is administered. 2. Diagnostic Coronary Angiography Using a guidewire, the guiding catheter is advanced into the ascending aorta and engaged at the coronary ostium. Coronary angiography is performed to assess lesion morphology, percent diameter stenosis, and lesion length. 3. Lesion Preparation: Pre dilatation, Atherectomy, Thrombus Aspiration, and Excimer Laser A PCI guidewire is advanced across the lesion, followed by balloon pre dilatation as required. For calcified lesions, atherectomy (e.g., Rotablator, Shockwave IVL) is performed when deemed necessary. For thrombotic lesions, thrombus aspiration or excimer laser therapy is used to remove intraluminal thrombus. 4. Treatment With Finalized Device and Post dilatation Based on lesion characteristics, drug eluting stents (DES) or drug coated balloons (DCB), or a combination thereof, are selected for treatment. Post dilatation with an appropriately sized balloon is performed as needed. 5. Final Angiographic Assessment The final angiographic results are evaluated to confirm optimal PCI outcomes. 6. Hemostasis Following sheath removal, hemostasis is achieved by manual compression or an approved vascular closure device. Workflow for DSS Imaging The use of the Dual Sensor System (DSS) in this clinical trial shall be conducted according to the following standardized procedures. 1. Baseline Imaging Prior to PCI (Mandatory) After guidewire crossing and before PCI, the DSS catheter is advanced across the lesion. A pullback is performed in the simultaneous IVUS or OFDI imaging mode to obtain baseline images. These images are used to evaluate lesion length, vessel diameter, and plaque characteristics (e.g., degree and distribution of calcification). Note (Allowance for Clinical Judgment) If the catheter cannot cross due to severe stenosis, lesion preparation (such as balloon pre dilatation or debulking using rotational atherectomy) may be performed to facilitate catheter passage. 2. Post PCI Imaging (Mandatory) After completion of PCI, the DSS catheter is reinserted, and another pullback in the simultaneous IVUS or OFDI mode is performed to obtain final images. These images will be used to assess the primary endpoint (image clarity) and the observational parameters specified in Section 7.1.2. 3. Additional Intraoperative Use (At Operator Discretion) In addition to steps 1 and 2, operators may use DSS at any clinically indicated time (for example, to assist in selecting a debulking device for calcified lesions, determining stent sizing, or planning bifurcation strategies). If additional imaging is performed, the purpose and findings must be recorded in the case report form (CRF). Use of IVUS only or OFDI only modes is also permitted at the operator discretion.

Outcome(s)

Primary Outcome

Efficacy Endpoint Proportion of clear images (defined as cross-sectional vascular images with more than or equal to 270 degrees of the vessel lumen visualized) in both IVUS and OFDI images obtained by simultaneous IVUS and OFDI image acquisition after PCI. Assessment method) At 1 mm intervals across the target lesion and 5 mm proximal and distal reference segments, both IVUS and OFDI images will be individually evaluated. Safety Endpoint Adverse events attributable to the Dual Sensor System (DSS). Examples include coronary artery dissection, coronary spasm, coronary occlusion, intravascular thrombosis within the imaged vessel, difficulty in DSS catheter removal, and device malfunctions (e.g., failure of DSS operation resulting in inability to obtain images).

Secondary Outcome

Efficacy Endpoints Device success rate Utilization status of each imaging mode (IVUS alone, OFDI alone, and simultaneous IVUS and OFDI imaging) Quantitative and qualitative parameters obtained from the DSS PCI procedural success rate Safety Endpoints Periprocedural adverse events, including death, stroke, non-fatal myocardial infarction, vascular complications, and bleeding events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Patients scheduled to undergo percutaneous coronary intervention (PCI) for complex coronary lesions. (2) Patients who are 18 years of age or older at the time of informed consent. (3) Patients who are able to understand the treatment and the purpose of the study, and who can provide written informed consent voluntarily.
Exclude criteria	(1) Patients scheduled to undergo PCI for ostial lesions or chronic total occlusions . (2) Patients for whom continuation of antiplatelet therapy is not feasible (e.g., those scheduled to undergo surgery requiring discontinuation of antiplatelet agents within 1 month after PCI. (3) Patients who are pregnant, breastfeeding, or possibly pregnant. (4) Patients with a history of severe hypersensitivity to iodinated contrast media. (5) Patients lacking the capacity to provide informed consent due to dementia, impaired consciousness, delirium, severe psychiatric disorders, or intellectual disability. (6) Patients deemed unsuitable for study participation by the principal investigator or sub-investigators.