CClinicalTrials.gg
Sign In
RecruitingNCT06657833DEBSCAN-IVLUpdated Sep 30, 2026

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

An interventional study of Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon and Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent in Coronary Artery Disease, sponsored by Fundación EPIC. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Fundación EPIC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Calcified Nodules
  • Calcified lesions
  • Drug eluting balloon
  • Drug eluting stent
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Other
    Drug Eluting Balloon (DEB)

    Device: 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

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

05

What researchers measure

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)

  5. SAFETY: No Reflow

    Freedom from no reflow

    Time frame: During Percutaneous Coronary Intervention (PCI)

  6. SAFETY: Thrombosis

    Freedom from thrombosis

    Time frame: During Percutaneous Coronary Intervention (PCI)

  7. SAFETY: MACE

    Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.

    Time frame: Up to 30 days

  8. SAFETY: Stent Thrombosis

    Freedom Stent thrombosis

    Time frame: During hospitalization

  9. SAFETY: Major bleeding event

    Freedom from Mayor bleeding event according to ≥ (BARC 3 criteria )

    Time frame: During hospitalization

  10. SAFETY: Stent Thrombosis

    Freedom from stent thrombosis

    Time frame: During hospitalization

  11. SAFETY: Hemodynamic stability

    Freedom for need for unplanned vasopressors/inotropes or ventricular support devices

    Time frame: During hospitalization

  12. EFFICACY: Minimal Lumen Diameter (MLD)

    Change in MLD Immediately before procedure, immediately after procedure

    Time frame: Day 0

  13. EFFICACY: Diameter Stenosis

    Percentaje of Diammeter Stenosis after PCI

    Time frame: Day 0

  14. EFFICACY: Minimal Lumen Diameter (MLD)

    Change in MLD during follow-up

    Time frame: 9 Months

  15. EFFICACY: Minimal Lumen Diammeter (MLD)

    Change in MLD during follow-up

    Time frame: 12 Months

  16. EFFICACY: Binary reestenosis

    Freedom from reestenosis by angiography during follow-up

    Time frame: 9 Months

  17. EFFICACY: Crossover rate

    Rate of stent change ( DEB to DES or DES to DEB) during follow-up

    Time frame: Day 0

  18. SAFETY: MACE

    Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.

    Time frame: 9 Months

  19. SAFETY: MACE

    Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.

    Time frame: 12 Months

  20. SAFETY: MACE

    Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.

    Time frame: 24 Months

  21. SAFETY: Myocardial Infarction

    Freedom from myocardial infarction

    Time frame: 9 Months

  22. SAFETY: Myocardial Infarction

    Freedom from myocardial infarction

    Time frame: 12 Months

  23. SAFETY: Myocardial Infarction

    Freedom from myocardial infarction

    Time frame: 24 Months

  24. SAFETY: Cardiac death

    Freedom from cardiac death

    Time frame: 12 Months

  25. SAFETY: Cardiac death

    Freedom from cardiac death

    Time frame: 24 Months

  26. SAFETY: Target Lesion Revascularization.

    Freedom from TLR

    Time frame: 9 Months

  27. SAFETY: Target Lesion Revascularization.

    Freedom from TLR

    Time frame: 12 Months

  28. SAFETY: Target Lesion Revascularization.

    Freedom from TLR

    Time frame: 24 Months

06

Study locations

15 of 15 sites recruiting
  • Leiden University Medical Center
    Leiden, Netherlands
    Recruiting
  • Hospital Del Mar
    Barcelona, 08003, Spain
    Recruiting
  • Hospital Universitario de La Paz
    Fuencarral-El Pardo, 28046, Spain
    Recruiting
  • Hospital Universitario de Galdakao-Usansolo
    Galdakao, 48960, Spain
    Recruiting
  • Hospital Universitari de Bellvitge
    L'Hospitalet de Llobregat, 08907, Spain
    Recruiting
  • Hospital Universitario de León
    León, 24008, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
    Recruiting
  • Hospital Universitario Puerta de Hierro
    Madrid, 28222, Spain
    Recruiting
  • Hospital Clínico San Carlos
    Moncloa-Aravaca, 28040, Spain
    Recruiting
  • Hospital Universitario de Navarra
    Pamplona, 31008, Spain
    Recruiting
  • Hospital General Universitario de Valencia
    Valencia, 46014, Spain
    Recruiting
  • Hospital Universitario y Politécnico La Fe
    Valencia, 46026, Spain
    Recruiting
  • Hospital Clínico Universitario de Valladolid
    Valladolid, 47003, Spain
    Recruiting
  • Hospital Universitario de Vigo
    Vigo, 36312, Spain
    Recruiting
  • Hospital Universitario Miguel Servet
    Zaragoza, 50009, Spain
    Recruiting
07

References and documents

Publications

  • 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. PubMed 32259392 ↗
  • 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. PubMed 28797410 ↗
  • 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. PubMed 37164599 ↗
  • 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. PubMed 31553205 ↗
  • 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. PubMed 34527034 ↗
  • 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. PubMed 32857188 ↗
  • Jurado-Roman A, Basile M, Montero-Cabezas JM, Rivero-Santana B, Zubiaur J, Garcia-Tejada J, Galeote G, Jimenez-Valero S, Perez de Prado A, Garcia-Tuchard A, Tebar D, Rumoroso JR, Gonzalvez A, Amat-Santos IJ, Jimenez-Diaz VA, Rumiz E, Sanz-Sanchez J, Vaquerizo B, Alfonso F, Moreno R. DEB or DES for the treatment of calcified nodules after intravascular lithotripsy: the DEBSCAN-IVL trial design. REC Interv Cardiol. 2025 Nov 12;8(2):100-106. doi: 10.24875/RECICE.M25000551. eCollection 2026 Apr-Jun. PubMed 42745725 ↗
08

Registry details

Key details

Study ID
NCT06657833
Lead sponsor
Fundación EPIC
Responsible party
Sponsor
First posted
Oct 26, 2024
Start date
Dec 17, 2024
Primary completion
Oct 30, 2027 (estimated)
Completion
Oct 30, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

FUNDACION EPIC
Contact
iepic@fundacionepic.org
0034987225638
ALFONSO JURADO ROMAN, MD,PhD
Contact
alfonsojuradoroman@gmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease→

Other studies from this sponsor

Fundación EPIC

Start the discussion