ClinicalTrials.gg
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

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Updated Sep 30, 20261 site addedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 33 studies in Coronary Artery Disease by Fundación EPIC — 13 open to participants now, 20 under way, none of them phase 3. Coronary Artery Disease · Fundación EPIC.

Planned enrollment
9th of 13
94 · median 200
Started
2024
with 5 others
No phase
11 of 33
7 open now
Primary completion
2026-12
later than 5 of 19 live
Registered
24th of 33
by date

Among the 33 studies in Coronary Artery Disease by Fundación EPIC, this one is the 9th largest by planned enrollment of the 13 interventional ones that give a count, is one of 6 that started in 2024, is one of 11 with no phase, reaches primary completion later than 5 of the 19 other live ones, and was the 24th registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

13 of the 33 studies in Coronary Artery Disease by Fundación EPIC are open now, in 7 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

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

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • Drug-coated balloon
  • Vasomotor function
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

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

  • Patients with any 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 \<30 ml/min/ 1.73 m2
  • Patients with >35 (may affect the evaluation qualitative diameter of the coronary artery).
  • Patients with symptomatic congestive heart failure.
  • Patients with significant inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, ).
  • Patients with heart transplant.
  • Patients with anemia ( \<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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

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)

06

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

07

Study locations

9 of 9 sites recruiting
08

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 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 25 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2024
First posted
Jun 7, 2024
StartActual
Oct 23, 2024
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 1, 2027
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Hospital de Merida · Mérida, Spain
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    1 site added
    Show site
    • Hospital de Merida · Mérida, Spain
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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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