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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)
Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)
Hospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGHospital Universitario de Cabueñes
Gijón, Spain
RECRUITINGHospital Universitario Juan Ramón Jiménez
Huelva, Spain
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).
Time frame: 8 months
Comparison of percentage of angiographic restenosis by quantitative coronary
Comparison of percentage of angiographic restenosis by quantitative coronary
Time frame: 8 months
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
Time frame: 8 months
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
Time frame: 8 months
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
Time frame: 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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitario de Leon
León, Spain
RECRUITINGHospital Universitario Lucus Augusti
Lugo, Spain
RECRUITINGHospital Universitario Central de Asturias
Oviedo, Spain
RECRUITINGHospital Provincial de Pontevedra
Pontevedra, Spain
RECRUITINGTime frame: 8 months