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Coronary Artery DiseaseDEBSCAN-IVLNCT06657833

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

A study testing 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 people with Coronary Artery Disease, run by Fundación EPIC at 15 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
15 sitesin 2 countries
Study dates
17 Dec 2024to 30 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

Trial locations and contacts

15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

FUNDACION EPIC contact

0034987225638

iepic@fundacionepic.org

ALFONSO JURADO ROMAN, MD,PhD contact

alfonsojuradoroman@gmail.com

15 sites in 2 countries

Spain14 sites, 14 recruiting

  • Hospital Del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Universitario de La Paz

    Fuencarral-El Pardo, 28046

    Recruiting

  • Hospital Universitario de Galdakao-Usansolo

    Galdakao, 48960

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

    Recruiting

  • Hospital Universitario de León

    León, 24008

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222

    Recruiting

  • Hospital Clínico San Carlos

    Moncloa-Aravaca, 28040

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia, 46014

    Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

    Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

    Recruiting

  • Hospital Universitario de Vigo

    Vigo, 36312

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Netherlands1 site, 1 recruiting

  • Leiden University Medical Center

    Leiden

    Recruiting

Other trials in Netherlands

About this study

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.

Being tested
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
Keywords
Calcified Nodules, Calcified lesions, Drug eluting balloon, Drug eluting stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06657833
Study groupRoleWhat they receive
Drug Eluting Balloon (DEB)OtherNot described
Receives: Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
Drug Eluting Stent (DES)OtherNot described
Receives: Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 9 Month

Secondary outcomes (28)

  1. SAFETY: Dissection

    Freedom from dissection

    Measured: During Percutaneous Coronary Intervention (PCI)

  2. SAFETY: Perforation

    Freedom from perforation

    Measured: During Percutaneous Coronary Intervention (PCI)

  3. SAFETY: Abrupt vessel closure

    Freedom from abrupt vessel closure

    Measured: During Percutaneous Coronary Intervention (PCI)

  4. SAFETY: Slow Flow

    Freedom from slow flow

    Measured: During Percutaneous Coronary Intervention (PCI)

  5. SAFETY: No Reflow

    Freedom from no reflow

    Measured: During Percutaneous Coronary Intervention (PCI)

  6. SAFETY: Thrombosis

    Freedom from thrombosis

    Measured: During Percutaneous Coronary Intervention (PCI)

  7. SAFETY: MACE

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

    Measured: Up to 30 days

  8. SAFETY: Stent Thrombosis

    Freedom Stent thrombosis

    Measured: During hospitalization

  9. SAFETY: Major bleeding event

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

    Measured: During hospitalization

  10. SAFETY: Stent Thrombosis

    Freedom from stent thrombosis

    Measured: During hospitalization

  11. SAFETY: Hemodynamic stability

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

    Measured: During hospitalization

  12. EFFICACY: Minimal Lumen Diameter (MLD)

    Change in MLD Immediately before procedure, immediately after procedure

    Measured: Day 0

  13. EFFICACY: Diameter Stenosis

    Percentaje of Diammeter Stenosis after PCI

    Measured: Day 0

  14. EFFICACY: Minimal Lumen Diameter (MLD)

    Change in MLD during follow-up

    Measured: 9 Months

  15. EFFICACY: Minimal Lumen Diammeter (MLD)

    Change in MLD during follow-up

    Measured: 12 Months

  16. EFFICACY: Binary reestenosis

    Freedom from reestenosis by angiography during follow-up

    Measured: 9 Months

  17. EFFICACY: Crossover rate

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

    Measured: Day 0

  18. SAFETY: MACE

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

    Measured: 9 Months

  19. SAFETY: MACE

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

    Measured: 12 Months

  20. SAFETY: MACE

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

    Measured: 24 Months

  21. SAFETY: Myocardial Infarction

    Freedom from myocardial infarction

    Measured: 9 Months

  22. SAFETY: Myocardial Infarction

    Freedom from myocardial infarction

    Measured: 12 Months

  23. SAFETY: Myocardial Infarction

    Freedom from myocardial infarction

    Measured: 24 Months

  24. SAFETY: Cardiac death

    Freedom from cardiac death

    Measured: 12 Months

  25. SAFETY: Cardiac death

    Freedom from cardiac death

    Measured: 24 Months

  26. SAFETY: Target Lesion Revascularization.

    Freedom from TLR

    Measured: 9 Months

  27. SAFETY: Target Lesion Revascularization.

    Freedom from TLR

    Measured: 12 Months

  28. SAFETY: Target Lesion Revascularization.

    Freedom from TLR

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start17 Dec 2024
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06657833
Sponsor's protocol ID
EPIC40-DEBSCAN-IVL
Acronym
DEBSCAN-IVL
Status last verified
Sep 2026
First submitted
21 Oct 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing 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 people with Coronary Artery Disease, run by Fundación EPIC at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact FUNDACION EPIC (0034987225638, iepic@fundacionepic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFFICACY: Late Lumen Loss (LLL) (time frame: 9 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06657833, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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