Preventive Drug-coated Balloon Angioplasty in Vulnerable... | NCT06365502

Status Module

Name	Class
Shanghai Shenqi Medical Technology Co., Ltd	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCB treatment	Experimental	Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment.	Device: Drug-coated balloon Drug: Guideline-directed medical treatment
Guideline-directed medical treatment	Active Comparator	Non-flow limited vulnerable plaque will be left with no intervention when the individual is randomized into guideline-directed medical treatment group. The individual will receive guideline-directed medical treatment alone.	Drug: Guideline-directed medical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug-coated balloon	Device	Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.	DCB treatment

Measure	Description	Time Frame
Target lesion failure (TLF)		At 24 months

Measure	Description	Time Frame
Target lesion failure (TLF)		At 30 days
Target lesion failure (TLF)		At 6 months
Target lesion failure (TLF)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be between 18 and 80 years of age
Subject must present with acute myocardial infarction or unstable angina planned for PCI
Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
Target lesion must have any two of the intravascular imaging criteria of PB >65%, MLA <3.5 mm^2 (OCT) or 4.0mm^2 (IVUS), FCT <75 μm, or maximal lipid arc >180°
Subject must provide written informed consent before any study-related procedure

Exclusion Criteria:

Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
Hypotension, shock, or need for mechanical support or intravenous vasopressors;
Creatinine clearance ≤30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR)
Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
Life expectancy <2 years for any
Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
The target lesion is located within 10 mm of the proximal or distal of stent
The target lesion cannot be in the left main coronary artery
The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
The target lesion is located in severe calcification or tortuosity of vessels
The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
The target lesion is located within the bypass graft artery

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases