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

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: 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 stent

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987225638; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: ALFONSO JURADO ROMAN, MD,PhD; Email: alfonsojuradoroman@gmail.com

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Recruiting
    • Leiden University Medical Center
• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
  • Fuencarral-El Pardo, Spain, 28046
    • Recruiting
    • Hospital Universitario de La Paz
  • Galdakao, Spain, 48960
    • Recruiting
    • Hospital Universitario de Galdakao-Usansolo
  • León, Spain, 24008
    • Recruiting
    • Hospital Universitario de Leon
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro
  • Moncloa-Aravaca, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Pamplona, Spain, 31008
    • Recruiting
    • Hospital Universitario de Navarra
  • Valencia, Spain, 46014
    • Recruiting
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario Y Politecnico La Fe
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clínico Universitario de Valladolid
  • Vigo, Spain, 36312
    • Recruiting
    • Hospital Universitario de Vigo
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Drug Eluting Balloon (DEB)	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 balloon
Other: Drug Eluting Stent (DES)	Device: Percutaneous 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	9 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAFETY: Dissection	Freedom from dissection	During Percutaneous Coronary Intervention (PCI)
SAFETY: Perforation	Freedom from perforation	During Percutaneous Coronary Intervention (PCI)
SAFETY: Abrupt vessel closure	Freedom from abrupt vessel closure	During Percutaneous Coronary Intervention (PCI)
SAFETY: Slow Flow	Freedom from slow flow	During Percutaneous Coronary Intervention (PCI)
SAFETY: No Reflow	Freedom from no reflow	During Percutaneous Coronary Intervention (PCI)
SAFETY: Thrombosis	Freedom from thrombosis	During Percutaneous Coronary Intervention (PCI)
SAFETY: MACE	Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.	Up to 30 days
SAFETY: Stent Thrombosis	Freedom Stent thrombosis	During hospitalization
SAFETY: Major bleeding event	Freedom from Mayor bleeding event according to ≥ (BARC 3 criteria )	During hospitalization
SAFETY: Stent Thrombosis	Freedom from stent thrombosis	During hospitalization
SAFETY: Hemodynamic stability	Freedom for need for unplanned vasopressors/inotropes or ventricular support devices	During hospitalization
EFFICACY: Minimal Lumen Diameter (MLD)	Change in MLD Immediately before procedure, immediately after procedure	Day 0
EFFICACY: Diameter Stenosis	Percentaje of Diammeter Stenosis after PCI	Day 0
EFFICACY: Minimal Lumen Diammeter (MLD)	Change in MLD during follow-up	12 Months
EFFICACY: Crossover rate	Rate of stent change ( DEB to DES or DES to DEB) during follow-up	Day 0
SAFETY: MACE	Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.	12 Months
SAFETY: MACE	Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.	24 Months
SAFETY: Myocardial Infarction	Freedom from myocardial infarction	12 Months
SAFETY: Myocardial Infarction	Freedom from myocardial infarction	24 Months
SAFETY: Cardiac death	Freedom from cardiac death	12 Months
SAFETY: Cardiac death	Freedom from cardiac death	24 Months
SAFETY: Target Lesion Revascularization.	Freedom from TLR	12 Months
SAFETY: Target Lesion Revascularization.	Freedom from TLR	24 Months
EFFICACY: Minimal Lumen Diameter (MLD)	Change in MLD during follow-up	9 Months
EFFICACY: Binary reestenosis	Freedom from reestenosis by angiography during follow-up	9 Months
SAFETY: MACE	Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.	9 Months
SAFETY: Myocardial Infarction	Freedom from myocardial infarction	9 Months
SAFETY: Target Lesion Revascularization.	Freedom from TLR	9 Months

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
• Jurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345
• Morofuji T, Kuramitsu S, Shinozaki T, Jinnouchi H, Sonoda S, Domei T, Hyodo M, Shirai S, Ando K. Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy. Catheter Cardiovasc Interv. 2021 Jan 1;97(1):10-19. doi: 10.1002/ccd.28896. Epub 2020 Apr 7.
• Lee T, Mintz GS, Matsumura M, Zhang W, Cao Y, Usui E, Kanaji Y, Murai T, Yonetsu T, Kakuta T, Maehara A. Prevalence, Predictors, and Clinical Presentation of a Calcified Nodule as Assessed by Optical Coherence Tomography. JACC Cardiovasc Imaging. 2017 Aug;10(8):883-891. doi: 10.1016/j.jcmg.2017.05.013.
• Sato T, Matsumura M, Yamamoto K, Shlofmitz E, Moses JW, Khalique OK, Thomas SV, Tsoulios A, Cohen DJ, Mintz GS, Shlofmitz RA, Jeremias A, Ali ZA, Maehara A. Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting. JACC Cardiovasc Interv. 2023 May 8;16(9):1024-1035. doi: 10.1016/j.jcin.2023.03.009.
• Ho HH, Lee JH, Khoo DZL, Hpone KKS, Li KFC. Shockwave intravascular lithotripsy and drug-coated balloon angioplasty in calcified coronary arteries: preliminary experience in two cases. J Geriatr Cardiol. 2021 Aug 28;18(8):689-691. doi: 10.11909/j.issn.1671-5411.2021.08.009. No abstract available.
• Iwasaki Y, Koike J, Ko T, Funatsu A, Kobayashi T, Ikeda T, Nakamura S. Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels. Heart Vessels. 2021 Feb;36(2):189-199. doi: 10.1007/s00380-020-01684-z. Epub 2020 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Drug eluting stent; Drug eluting balloon; Calcified lesions; Calcified Nodules
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: EPIC40-DEBSCAN-IVL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No