This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
The bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions. This multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now "gold standard" technique of the "provisional stenting" with the paclitaxel DES in the main branch.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
190
Coronary angioplasty using the paclitaxel-coated balloon catheter
Coronary angioplasty using the paclitaxel-eluting stent
Hospital Universitario Infanta Cristina
Badajoz, Badajoz, Spain
Hospital Universitari Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Complejo Hospitalario San Pedro de Alcantara
Cáceres, Caceres, Spain
Hospital Universitario Puerta del Mar
Late Lumen Loss (LLL)
Assessment of the difference between both groups regarding the Late Lumen Loss (LLL) in main vessel and side branch, measured at late angiographic follow-up at 9 months
Time frame: Late angiographic follow-up (9 months)
Restenosis
Assessment of the difference between both groups regarding the Restenosis in both branches (proximal part of the main vessel, distal part of the main vessel and side branch), measured at late angiographic follow-up at 9 months
Time frame: Late angiographic follow-up (9 months)
Thrombosis rate
Assesment of the thrombosis rate
Time frame: Late angiographic follow-up (9 months)
Target Lesion Revascularization (TLR)
Assessment of the Target Lesion Revascularization (TLR) at late angiographic follow-up (9 months) if dilatation by restenosis or previous angiography due to angina
Time frame: Late angiographic follow-up (9 months)
Major Adverse Cardiac Events (MACE)
Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis-
Time frame: Late angiographic follow-up (9 months)
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Cadiz, Cadiz, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cadiz, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, Spain
Hospital Virgen de la Salud
Toledo, Toledo, Spain