Compares two treatments for coronary artery disease in large heart vessels
Tests a drug-coated balloon against a drug-eluting stent in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Barcelona, Gijón, Huelva, León, Lugo, Mérida, Oviedo, Pontevedra, and Tarragona, SpainSee the 9 sites
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario de CabueñesGijón, SpainTaking people
- Hospital Universitario Juan Ramon JimenezHuelva, SpainTaking people
- Hospital Universitario De LeonLeón, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital de MéridaMérida, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- Hospital Provincial de PontevedraPontevedra, SpainTaking people
- Hospital Universitari de Tarragona Joan XXIIITarragona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT06448637
- Record updated
- 30 September 2026
- Original 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 mmRead full original descriptionShow less
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
Inclusion: 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: Patients who received a combination of DES and DCB in the same vessel; Patients who meet at least one of the following conditions are excluded:; 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 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; Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG); 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); Pregnant female patients; Patients included in other clinical trials with active follow-up.