Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Shao-Liang Chen, MD
CONTACT
Jing Kan, PhD
CONTACT
Lead
Nanjing First Hospital, Nanjing Medical University
A prospective, randomized, controlled, open-label, multicenter trial with blinded endpoint adjudication (PROBE design) A total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT,will be assigned at 1:1 ratio to: Experimental Group: PCI with contemporary DES + GDMT. Control Group: GDMT alone. Angiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (\>80%) of PCI success, or 3) a visually estimated diameter stenosis (DS) of \<90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions are considered amenable to PCI with DES by an interventional cardiologist. Randomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center. Complete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days. However, it is recommended that chronic total occlusions are only treated if they supply viable myocardium (preserved regional wall motion or viability by cardiac MR or PET). All PCIs in any lesion with reference vessel diameter ≥2.5 mm MUST be guided by intravascular imaging (IVUS or OCT). The use of mechanical circulatory system (including IABP, Impella, or ECMO) is left at operator's discretion. Drug-coated balloon (DCB) alone is not recommended, but the combination of DES with DCB (e.g. for diffuse distal disease or side branch treatment of a bifurcation lesion) is left to operator's discretion. Both arms receive optimized GDMT according to current guidelines. Given the nature of the intervention (PCI vs. no PCI), treating physicians and patients cannot be blinded. To minimize bias, a PROBE design is employed with a blinded independent Clinical Events Committee (CEC), blinded core laboratories, and blinded statisticians. The catheterization laboratory team is unblinded but not involved in follow-up decisions or endpoint assessments. Clinic/telephone follow-up is conducted at 30 days, 3, 6, 9, 12 months and then yearly until the time that the last patient enrolled has reached 12-month follow-up. In addition, at this time, a final "sweep" visit (phone call) will be made to all patients who have not had a follow-up completed within 30 days. All subjects in both groups receive evidence based GDMT and dual antiplatelet therapy (DAPT) per guidelines throughout the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
