For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.
Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
450
Sirolimus-eluting stent will be implanted
Paclitaxel-eluting stent will be implanted
Deutsches Herzzentrum Muenchen
Munich, Germany
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany
Late luminal loss at follow-up angiography
Time frame: 6-8 months
Need of target lesion revascularization.
Time frame: 12 months
Combined incidence of death or myocardial infarction.
Time frame: 12 months
Incidence of stent thrombosis.
Time frame: 12 months
Incidence of binary restenosis at follow-up angiography
Time frame: 6-8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.