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

Fundación EPIC128 enrolled

Overview

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).

Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Coronary Artery Disease

Interventions

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

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 stentDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients must meet all inclusion criteria: * 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. Exclusion Criteria: Patients must not meet any criteria * 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. * Life expectancy \<1 year. * Index lesion at left main stem. * Aorto-ostial lesion. * Target lesion previously treated with stents or DEB. * High thrombus burden in the target lesion (TIMI thrombus scale≥3).

Locations (12)

Hospital Del Mar

Barcelona, Spain

RECRUITING

Hospital Universitario de La Paz

Fuencarral-El Pardo, Spain

RECRUITING

Outcomes

Primary Outcomes

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

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