Actively Recruiting
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)
Led by Fundación EPIC · Updated on 2026-03-23
94
Participants Needed
7
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation, or acute coronary syndrome with ST elevation more than 48 hours after the event
- Patients with new lesions in vessels 3.5 mm or larger without significant calcification or visible thrombus
- Patients who have given written informed consent after being informed about the study
You will not qualify if you...
- Contraindication to acetylcholine or nitroglycerin
- History of coronary vasospasm or spontaneous coronary artery dissection
- Significant medical, surgical, or psychiatric conditions affecting safety or study outcome
- Received both drug-eluting stent and drug-coated balloon in the same vessel
- Glomerular filtration rate below 30 ml/min/1.73 m2
- Body mass index over 35
- Symptomatic congestive heart failure
- Significant autoimmune inflammatory conditions or immunomodulatory medication use
- History of heart transplant
- Anemia (hemoglobin less than 12 g/dL in men or less than 10 g/dL in women)
- Women of childbearing age with positive pregnancy test
- Pregnant women
- Participation in other clinical trials with active follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Universitario de Cabueñes
Gijón, Spain, 33394
Actively Recruiting
3
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain, 21005
Actively Recruiting
4
Hospital Universitario de Leon
León, Spain, 24008
Actively Recruiting
5
Hospital Universitario Lucus Augusti
Lugo, Spain, 270003
Actively Recruiting
6
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
7
Hospital Provincial de Pontevedra
Pontevedra, Spain, 36071
Actively Recruiting
Research Team
I
IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD
CONTACT
F
FUNDACION EPIC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here