The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Sirolimus formulated coronary eluting stent
Bare metal coronary stent
Azienda Ospedaliero - Universitaria S.Anna
Ferrara, FE, Italy
Policlinico Universitario "Agostino Gemelli"
Roma, RM, Italy
Azienda Ospedaliera S. Giovanni - Addolorata
Roma, RM, Italy
Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"
Torino, TO, Italy
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT
1 month for the BMS arm; 3 months for the DES arm
Time frame: within 3 months from index procedure
Percentage of malapposed stent struts
Time frame: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Percentage of malapposed and uncovered stent struts
Time frame: 1 month (BMS arm) / 3 months (DES arm)
Neointimal growth and neointimal thickness
Time frame: 1 month (BMS arm) / 3 months (DES arm)
Angiographic in-stent and in-segment endpoints
reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss
Time frame: immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Clinical composite endpoints
* Cardiac death/Target vessel MI/Clinically indicated TLR * All death/All MI/All TVR (including TLR)
Time frame: At 1, 3 and 12 months
Stent Thrombosis
Time frame: during index procedure, immediately after index procedure, 1 month, 3 months, 12 months
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ULSS n°3 - Ospedale Civile
Bassano del Grappa, VI, Italy
University Medical Centre Utrecht
Utrecht, Netherlands