The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de León
León, Spain
Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation.
Time frame: 3 months
Percentage of covered struts at 3 months OCT after stent implantation.
Time frame: 3 months
Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation.
Time frame: 3 months
Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation.
Time frame: 3 months
Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.
Time frame: 3 months
Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.
Time frame: 30 days and 3 months and 6 months and 12 months
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Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .
Time frame: 30 days and 3 months and 6 months and 12 months
Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.
Time frame: 1 month and 2 months and 3 months
Healing Score at 1 month and 3 months OCT after stent implantation .
Time frame: 1 month and 2 months and 3 months