Phase
Condition
Angina
Coronary Artery Disease
Chest Pain
Treatment
Drug-coated balloon
Guideline-directed medical treatment
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must be between 18 and 80 years of age
Subject must present with acute myocardial infarction or unstable angina planned forPCI
Successful stent implantation (i.e., residual stenosis less than 20%) must be donein culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or lessthan 0.8)
Subject must have at least one native non-culprit lesion with visually estimatedstenosis 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
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 studydevices, including paclitaxel, etc) that cannot be adequately pre-medicated
Subject is receiving immunosuppressant therapy or has known immunosuppressive orsevere 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 forestimated GFR)
Left ventricular ejection fraction<30% by the most recent imaging test within 30days before procedure (echo, MRI, contrast left ventriculography or others)
Life expectancy <2 years for any
Subject is currently participating in another investigational drug or deviceclinical study that has not yet completed its primary endpoint
Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation 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 thebranch 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 theostium)
The target lesion is located within the bypass graft artery
Study Design
Study Description
Connect with a study center
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150000
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.