Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR).
Damien Collison, Matthaios Didagelos, Muhammad Aetesam-Ur-Rahman...
https://pubmed.ncbi.nlm.nih.gov/34279606/Actively Recruiting
Led by Korea University Guro Hospital · Updated on 2023-12-27
700
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the treatment strategies for patients with coronary artery disease undergoing stent implantation. This trial compares whether using combined guidance from optical coherence tomography OCT and fractional flow reserve FFR during the procedure improves outcomes compared to the standard approach guided only by conventional coronary angiography. The study aims to clarify if the combined method offers better clinical effectiveness and therapeutic impact than angiography alone. Participants are randomly assigned to one of two groups one group will receive percutaneous coronary intervention PCI guided by conventional angiography, where procedural decisions are based on angiographic imaging. The other group will undergo PCI guided concurrently by both OCT and FFR, with procedural optimization determined by these combined assessments. Both strategies involve coronary stent implantation and evaluation of lesion and stent status using their respective imaging or physiological methods. During the study, participants will be monitored for one year to assess the rate of target vessel failure as the primary outcome. Secondary outcomes include the rates of all-cause mortality, myocardial infarction, target vessel revascularization, any revascularization, stent thrombosis at various stages, and bleeding events defined by BARC criteria. The study includes informed consent, clinical follow-up, and outcome assessments to evaluate the benefits and risks of the two PCI guidance methods over the year following intervention.
CONDITIONS
Concurrent OCT and FFR-guided PCI in CAD
D
Dong Oh Kang, MD, PhD
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Korea University Guro Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo percutaneous coronary intervention (PCI) guided either by conventional angiography or by concurrent optical coherence tomography (OCT) and fractional flow reserve (FFR) to optimize stent implantation.
1 procedure visit (in-person)
Duration - Up to 1 year post-procedure
Participants are monitored for clinical outcomes including vessel failure, myocardial infarction, revascularization, stent thrombosis, and bleeding for up to 1 year after treatment.
Periodic follow-up visits over 1 year
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/31112213/Jennifer S Lawton, Jacqueline E Tamis-Holland, Sripal Bangalore...
https://pubmed.ncbi.nlm.nih.gov/34882436/Korea University Guro Hospital
Lead Sponsor