Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Placement of a Xience V® stent within a restenosed bare metal stent.
Hopital de Rangueil - Chu
Toulouse, France
Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®
Time frame: 9 months
Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent
Time frame: 9 months
Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent
Time frame: 9 months
Evaluation by QCA of the in-stent binary restenosis rate
Time frame: 9 months
Evaluation of the in-segment binary restenosis rate
Time frame: 9 months
Evaluation by QCA of in-segment late loss
Time frame: 9 months
Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent
Time frame: 9 months
Evaluation by IVUS of the rate of late incomplete apposition
Time frame: 9 months
Document the number of confirmed stent thrombosis
Time frame: 1, 8, 9, 12 and 24 months
-Document the number of confirmed revascularizations (TLR, TVR)
Time frame: 1, 8, 9, 12 and 24 months
Document the rate of MACE
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Time frame: 1, 8, 9, 12 and 24 months