Health TrialsbyHealthPanel

DCB vs. DES in Bifurcation Coronary Lesions

ConditionsCoronary Artery DiseaseDCB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be age ≥18 years.

Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.

Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial

Subject is willing to comply with all protocol-required follow-up evaluations.

Disqualifiers

Patient with STEMI (within 3 days from the onset of chest pain to coronarography).

Patient has known allergy to the study balloon/stent system.

Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.

Patient is pregnant or nursing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paclitaxel drug-coated balloons

    Device

    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

    Device

    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

    Device

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

Treatment groups

321 Participants
are divided into 3 treatment groups
Group A: Device: Paclitaxel drug-coated-balloonsExperimental treatment 1 intervention
Group B: Device: Sirolimus drug-coated-balloonsExperimental treatment 1 intervention
Group C: Device: new generation drug-eluting-stentsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions

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

Time frame
6-9-month
2

6-9-Month CT-FFR or Invasive FFR: % Max Stenosis (Main + Side Branch)

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

Time frame
6-9-month

Secondary outcomes

1

MACE

The MACE was defined as a composite of total mortality, TVR, and spontaneous TV-MI.

Time frame
24 +/- 1 months
2

Cardiac death

Cardiac death rates at 24+/- 1 months follow-up

Time frame
24+/- 1 months
3

All-cause death

All-cause death rates at 24+/- 1 months follow-up

Time frame
24+/- 1 months
4

Q-wave MI

Q-wave MI rates at 24+/- 1 months follow-up

Time frame
24+/- 1 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Lead sponsor

Source ClinicalTrials.gov
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