DCB vs. DES in Bifurcation Coronary Lesions

Condition(s) studied

Investigational drug(s) / intervention(s)

Paclitaxel drug-coated balloons: Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

Sirolimus drug-coated balloons: Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

New generation drug-eluting stent: Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

Study summary

This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter \>2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled.

Before participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained.

Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines/consensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.

Eligibility

Primary outcome measure(s)

• 6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions — 6-9-month
  6-9-month CT-scan FFR (core lab) * 6-9-month Main vessel CT-FFR * 6-9-month Side branch CT-FFR or If invasive coronary angiography indicated at 6-9 months: * invasive FFR of Main vessel * invasive FFR of Side branch
• 6-9-Month CT-FFR or Invasive FFR: % Max Stenosis (Main + Side Branch) — 6-9-month
  6-9-month CT-scan FFR (core lab): * Main vessel % maximum stenosis * Side branch % maximum stenosis or If invasive coronary angiography indicated at 6-9 months: * Main vessel % maximum stenosis * Side branch % maximum stenosis

Trial sites (17)

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