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DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients >18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and

Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;

Lesion to treat in a vessel between 2.5 and 4 mm.

Disqualifiers

Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.

Pregnant or breastfeeding patients.

Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.

Impossibility to maintain double antiplatelet treatment during at least 1 month.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

    Device

    Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon

  • Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

    Device

    Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Drug Eluting Balloon (DEB)Other 1 intervention
Group B: Drug Eluting Stent (DES)Other 1 intervention

Trial outcomes

Primary outcomes

1

EFFICACY: Late Lumen Loss (LLL)

Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 9-month follow-up

Time frame
9 Month
2

EFFICACY: Net Lumen Gain (NLG)

Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 9-month follow-up and MLD at the lesion site at baseline

Time frame
9 Month

Secondary outcomes

1

SAFETY: Dissection

Freedom from dissection

Time frame
During Percutaneous Coronary Intervention (PCI)
2

SAFETY: Perforation

Freedom from perforation

Time frame
During Percutaneous Coronary Intervention (PCI)
3

SAFETY: Abrupt vessel closure

Freedom from abrupt vessel closure

Time frame
During Percutaneous Coronary Intervention (PCI)
4

SAFETY: Slow Flow

Freedom from slow flow

Time frame
During Percutaneous Coronary Intervention (PCI)

Other outcomes

Sponsors and contacts

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Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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