Coronary Artery Disease
Conditions
Keywords
Drug-coated balloon, Vasomotor function
Brief 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
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
Interventions
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)
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of percentage of angiographic restenosis by quantitative coronary | 8 months | Comparison of percentage of angiographic restenosis by quantitative coronary |
| Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography | 8 months | Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography |
| Comparison of the minimum luminal area of the treated segment by optical coronary tomography | 8 months | Comparison of the minimum luminal area of the treated segment by optical coronary tomography |
| Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group | 8 months | Percentage of of strut coverage by OCT in the DES group |
| 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 | 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 |
Countries
Spain
Contacts
CONTACTIÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed