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
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.
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
Parallel
Drug Coated Balloon (DCB)
DeviceDrug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)
Drug Eluting Stent (DES)
DeviceDrug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)
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).
Comparison of percentage of angiographic restenosis by quantitative coronary
Comparison of percentage of angiographic restenosis by quantitative coronary
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
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
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
Click on the lead sponsor to view all of their trials.
