Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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: 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.

Treatments Being Tested

DEVICE

Drug Coated Balloon (DCB)

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

DEVICE

Drug Eluting Stent (DES)

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

Locations (7)

Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Cabueñes
Gijón, Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain
Hospital Universitario de Leon
León, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Provincial de Pontevedra
Pontevedra, Spain