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RecruitingNCT06448637Updated Sep 30, 2026

DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

An interventional study of Drug Coated Balloon (DCB) and Drug Eluting Stent (DES) in Coronary Artery Disease, sponsored by Fundación EPIC. Recruiting at 9 sites in Spain. 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
94
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Read the detailed description

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Drug-coated balloon
  • Vasomotor function
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients who meet all of the following conditions are included.

  • Patients aged ≥ 18 years and;
  • Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
  • Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
  • Patients who have been informed of the characteristics of the study and have provided their written informed consent.

Exclusion criteria

Exclusion Criteria:

Patients who meet at least one of the following conditions are excluded:

  • Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
  • Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.
  • Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.
  • Patients who received a combination of DES and DCB in the same vessel
  • Patients with glomerular filtration rate \<30 ml/min/ 1.73 m2
  • Patients with body mass index >35 (may affect the evaluation qualitative diameter of the coronary artery).
  • Patients with symptomatic congestive heart failure.
  • Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
  • Patients with heart transplant.
  • Patients with anemia (Hb \<12 g/dL in men and \<10 g/dL in women).
  • Patients, women of childbearing age with a positive pregnancy test.
  • Pregnant female patients.
  • Patients included in other clinical trials with active follow-up.
04

Study design

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

Study arms

  • Active comparator
    Drug Coated Balloon (DCB)

    Drug Coated Balloon (DCB)

    Device: Drug Coated Balloon (DCB)

  • Experimental
    Drug Eluting Stent (DES)

    Drug Eluting Stent (DES)

    Device: Drug Eluting Stent (DES)

Interventions

  • DeviceDrug Coated Balloon (DCB)

    Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)

  • DeviceDrug Eluting Stent (DES)

    Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

05

What researchers measure

Primary outcomes

  1. Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).

    Percentage of vessels with a positive response to Ach, defined as \>4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).

    Time frame: 8 months

Secondary outcomes

  1. Comparison of percentage of angiographic restenosis by quantitative coronary

    Comparison of percentage of angiographic restenosis by quantitative coronary

    Time frame: 8 months

  2. Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography

    Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography

    Time frame: 8 months

  3. Comparison of the minimum luminal area of the treated segment by optical coronary tomography

    Comparison of the minimum luminal area of the treated segment by optical coronary tomography

    Time frame: 8 months

  4. Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group

    Percentage of of strut coverage by OCT in the DES group

    Time frame: 8 months

  5. Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months

    Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months

    Time frame: 8 months

06

Study locations

9 of 9 sites recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    Recruiting
  • Hospital Universitario de Cabueñes
    Gijón, 33394, Spain
    Recruiting
  • Hospital Universitario Juan Ramón Jiménez
    Huelva, 21005, Spain
    Recruiting
  • Hospital Universitario de Leon
    León, 24008, Spain
    Recruiting
  • Hospital Universitario Lucus Augusti
    Lugo, 270003, Spain
    Recruiting
  • Hospital de Merida
    Mérida, 06800, Spain
    Recruiting
  • Hospital Universitario Central de Asturias
    Oviedo, 33011, Spain
    Recruiting
  • Hospital Provincial de Pontevedra
    Pontevedra, 36071, Spain
    Recruiting
  • Hospital Universitari de Tarragona Joan XXIII
    Tarragona, 43005, Spain
    Recruiting
07

References and documents

Publications

  • Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046. PubMed 32138967 ↗
  • Nakamura T, Brott BC, Brants I, Panchal D, Li J, Chen JP, King SB 3rd, Chronos N, Hou D. Vasomotor function after paclitaxel-coated balloon post-dilation in porcine coronary stent model. JACC Cardiovasc Interv. 2011 Feb;4(2):247-55. doi: 10.1016/j.jcin.2010.08.028. PubMed 21349465 ↗
  • Gutierrez E G-LJ, Escaned J, Cruz I, Ojeda S, Romaguera R, Moreno R. Valoración de la función endotelial y provocación de vasoespasmo coronario mediante infusión intracoronaria de acetilcolina. Documento técnico de la ACI-SEC. REC Interv Cardiol. 2021;3(4):286-296.
  • Gomez-Lara J, Oyarzabal L, Ortega-Paz L, Brugaletta S, Romaguera R, Salvatella N, Roura G, Rivero F, Fuentes L, Alfonso F, Otaegui I, Vandeloo B, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary Endothelium-Dependent Vasomotor Function After Drug-Eluting Stent and Bioresorbable Scaffold Implantation. J Am Heart Assoc. 2021 Nov 16;10(22):e022123. doi: 10.1161/JAHA.121.022123. Epub 2021 Nov 3. PubMed 34729992 ↗
  • Brugaletta S, Heo JH, Garcia-Garcia HM, Farooq V, van Geuns RJ, de Bruyne B, Dudek D, Smits PC, Koolen J, McClean D, Dorange C, Veldhof S, Rapoza R, Onuma Y, Bruining N, Ormiston JA, Serruys PW. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? Eur Heart J. 2012 Jun;33(11):1325-33. doi: 10.1093/eurheartj/ehr466. Epub 2012 Apr 16. PubMed 22507972 ↗
08

Registry details

Key details

Study ID
NCT06448637
Lead sponsor
Fundación EPIC
Responsible party
Sponsor
First posted
Jun 7, 2024
Start date
Oct 23, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD
Contact
inigo.lozano@fundacionepic.org
0034630901145
FUNDACION EPIC
Contact
iepic@fundacionepic.org
0034987876135

Oversight

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

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