Concurrent OCT and FFR-guided PCI in CAD

Browse trials for

• Coronary Artery Disease 5,587

Keywords

• Optical coherence tomography
• Fractional flow reserve
• Angiography
• Coronary artery disease
• Percutaneous coronary intervention
• Drug-eluting stent

Study arms

• Active comparator
  Angiography-guided PCI group

  This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.

  Diagnostic Test: Coronary angiography

• Experimental
  Concurrent OCT/FFR-guided PCI group

  This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.

  Diagnostic Test: optical coherence tomography and fractional flow reserve · Diagnostic Test: Coronary angiography

Interventions

• Diagnostic testoptical coherence tomography and fractional flow reserve

  The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.

• Diagnostic testCoronary angiography

  The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography

Primary outcomes

1. Rate of target vessel failure (TVF)

   a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization

   Time frame: 1-year

Secondary outcomes

1. Rate of all-cause mortality

   cardiac and non-cardiac death

   Time frame: 1-year

2. Rate of any myocardial infarction (MI)

   myocardial infarction due to target vessel and non-target vessel failure

   Time frame: 1-year

3. Rate of clinically-driven target vessel revascularization (TVR)

   clinically-driven target vessel revascularization

   Time frame: 1-year

4. Rate of any revascularization

   clinically-driven target lesion and non-target lesion revascularization

   Time frame: 1-year

5. Rate of stent thrombosis (acute, subacute, late, very late)

   stent thrombosis based on presenting time after the index procedure

   Time frame: 1-year

6. Rate of BARC-defined bleeding

   clinically-relevant bleeding event based on BARC classification

   Time frame: 1-year

Other outcomes

1. FFR optimization rate

   1\) Post-PCI FFR ≥ 0.90, or 2) Post-PCI FFR (LAD) ≥ 0.82, or 3) Post-PCI FFR (non-LAD) ≥ 0.88, 4) Stent-segment ΔFFR ≤0.05

   Time frame: Immediately after index procedure

2. OCT optimization rate

   1\) Post-PCI MSA ≥ 4.5 mm2, and 2) Post-PCI expansion ≥ 80%

   Time frame: Immediately after index procedure

Publications

• Johnson TW, Raber L, di Mario C, Bourantas C, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas K, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2019 Aug 14;40(31):2566-2584. doi: 10.1093/eurheartj/ehz332. PubMed 31112213 ↗
• Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e4-e17. doi: 10.1161/CIR.0000000000001039. Epub 2021 Dec 9. PubMed 34882436 ↗
• Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449. PubMed 34279606 ↗

Individual participant data

Plan to share: Undecided — Individual participant data will be available to qualified researchers only upon reasonable request and appropriate proposal to the principal investigator.