Coronary Artery Disease
Conditions
Keywords
Calcified Nodules, Calcified lesions, Drug eluting balloon, Drug eluting stent
Brief summary
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).
Detailed description
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.
Interventions
DEVICEPercutaneous 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 balloon
DEVICEPercutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY: Late Lumen Loss (LLL) | 9 Month | 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 |
| EFFICACY: Net Lumen Gain (NLG) | 9 Month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SAFETY: Dissection | During Percutaneous Coronary Intervention (PCI) | Freedom from dissection |
| SAFETY: Perforation | During Percutaneous Coronary Intervention (PCI) | Freedom from perforation |
| SAFETY: Abrupt vessel closure | During Percutaneous Coronary Intervention (PCI) | Freedom from abrupt vessel closure |
| SAFETY: Slow Flow | During Percutaneous Coronary Intervention (PCI) | Freedom from slow flow |
| SAFETY: No Reflow | During Percutaneous Coronary Intervention (PCI) | Freedom from no reflow |
| SAFETY: Thrombosis | During Percutaneous Coronary Intervention (PCI) | Freedom from thrombosis |
| SAFETY: MACE | Up to 30 days | Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization. |
| SAFETY: Stent Thrombosis | During hospitalization | Freedom Stent thrombosis |
| SAFETY: Major bleeding event | During hospitalization | Freedom from Mayor bleeding event according to ≥ (BARC 3 criteria ) |
| SAFETY: Hemodynamic stability | During hospitalization | Freedom for need for unplanned vasopressors/inotropes or ventricular support devices |
| EFFICACY: Minimal Lumen Diameter (MLD) | Day 0 | Change in MLD Immediately before procedure, immediately after procedure |
| EFFICACY: Diameter Stenosis | Day 0 | Percentaje of Diammeter Stenosis after PCI |
| EFFICACY: Minimal Lumen Diammeter (MLD) | 12 Months | Change in MLD during follow-up |
| EFFICACY: Binary reestenosis | 9 Months | Freedom from reestenosis by angiography during follow-up |
| EFFICACY: Crossover rate | Day 0 | Rate of stent change ( DEB to DES or DES to DEB) during follow-up |
| SAFETY: Myocardial Infarction | 9 Months | Freedom from myocardial infarction |
| SAFETY: Cardiac death | 12 Months | Freedom from cardiac death |
| SAFETY: Target Lesion Revascularization. | 9 Months | Freedom from TLR |
Countries
Netherlands, Spain
Contacts
CONTACTFUNDACION EPIC
CONTACTALFONSO JURADO ROMAN, MD,PhD
Outcome results
None listed