Coronary Artery DiseaseNCT06448637
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)
A study testing Drug Coated Balloon (DCB) and Drug Eluting Stent (DES) in people with Coronary Artery Disease, run by Fundación EPIC at 9 sites in Spain.
Trial 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 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?
- Drug Coated Balloon (DCB) and Drug Eluting Stent (DES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 9 sitesSpain
- Study dates
- 23 Oct 2024to 1 Dec 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 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario de Cabueñes
Gijón, 33394
- Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005
- Recruiting
Hospital Universitario de Leon
León, 24008
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, 270003
- Recruiting
Hospital de Merida
Mérida, 06800
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
- Recruiting
Hospital Provincial de Pontevedra
Pontevedra, 36071
- Recruiting
Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43005
About this study
Official title: DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)
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
- Conditions
- Coronary Artery Disease
- Being tested
- Drug Coated Balloon (DCB), Drug Eluting Stent (DES)
- Keywords
- Drug-coated balloon, Vasomotor function
- 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.
Drug Coated Balloon (DCB)Device
Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)
Drug Eluting Stent (DES)Device
Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated Balloon (DCB) | Active comparator | Drug Coated Balloon (DCB) Receives: Device: Drug Coated Balloon (DCB) |
| Drug Eluting Stent (DES) | Experimental | Drug Eluting Stent (DES) Receives: Device: Drug Eluting Stent (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 months
Secondary outcomes (5)
Comparison of percentage of angiographic restenosis by quantitative coronary
Comparison of percentage of angiographic restenosis by quantitative coronary
Measured: 8 months
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
Measured: 8 months
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
Measured: 8 months
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
Measured: 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
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start23 Oct 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448637
- Sponsor's protocol ID
- EPIC37-DEBORA
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32138967Nakamura 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 21349465Gutierrez 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 34729992Brugaletta 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)
- ClinicalTrials.gov ID
- NCT06448637
- Acronym / sponsor ID
- EPIC37-DEBORA
- Conditions
- Coronary Artery Disease
- Keywords
- Drug-coated balloon, Vasomotor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Coated Balloon (DCB) | Active comparator | Device: Drug Coated Balloon (DCB)Drug Coated Balloon (DCB) |
| Drug Eluting Stent (DES) | Experimental | Device: Drug Eluting Stent (DES)Drug Eluting Stent (DES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Coated Balloon (DCB)Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI) | Device | Drug Coated Balloon (DCB) |
| Drug Eluting Stent (DES)Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI) | Device | Drug Eluting Stent (DES) |
Primary outcome
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
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).
5 secondary outcomes
Comparison of percentage of angiographic restenosis by quantitative coronary
Time frame: 8 months
Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography
Time frame: 8 months
Comparison of the minimum luminal area of the treated segment by optical coronary tomography
Time frame: 8 months
Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 32138967Yerasi 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.
- Background: PubMed 21349465Nakamura 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.
- BackgroundGutierrez 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.
- Background: PubMed 34729992Gomez-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.
- Background: PubMed 22507972Brugaletta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug Coated Balloon (DCB) and Drug Eluting Stent (DES) in people with Coronary Artery Disease, run by Fundación EPIC at 9 sites in Spain.
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 5 inclusion and 14 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 9 sites in Spain. 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 IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD (0034630901145, inigo.lozano@fundacionepic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06448637, which also lists 5 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.