RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy

NARecruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2029

Conditions
Ischemic Cardiomyopathy
Interventions
PROCEDURE

Physiology-and imaging-guided PCI

"The criteria for performing revascularization are as follows~1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (\>90%)~2. In vessels meeting the above criteria, IVUS findings consistent with either:~ * Minimum lumen area (MLA) ≤ 3 mm²~ * 3 mm² \< MLA ≤ 4 mm² and plaque burden \>70%~For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them:~1. Post-PCI FFR \> 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR \> 0.80 to achieve functional complete revascularization.~2. Post-PCI ΔFFR (defined as \[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05 is recommended.~3. On IVUS, achieving a minimum stent area (MSA) \> 5.5 mm² and MSA/average reference lumen \> 80% is recommended."

DRUG

Optimal medical treatment

All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.

Trial Locations (1)

03080

RECRUITING

Seoul National University Hospital, Seoul

All Listed Sponsors
collaborator

Seoul National University Bundang Hospital

OTHER

collaborator

Seoul National University Boramae Hospital

OTHER

lead

Seoul National University Hospital

OTHER