The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.
Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind), non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a 2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™ (everolimus-eluting) stent. In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients in total), at baseline (post-procedure) and at 9-month follow-up. All patients will be followed clinically for up to 5 years after stent implantation. Repeat angiography will be performed in all patients at 9 months after the index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
Drug eluting stent implantation in the treatment of coronary artery disease.
Drug eluting stent implantation in the treatment of coronary artery disease
In-stent luminal late loss at 9 months after stent implantation (off-line QCA).
Time frame: 9 months
PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate
Time frame: Hospital discharge
ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate
Time frame: 9 months
IVUS (in a subset of patients): Minimal lumen area, Vessel volume, Lumen volume, Neointimal hyperplasia, Volume obstruction, Incomplete stent apposition, Plaque behind the stent struts
Time frame: 9 months
DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR)
Time frame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years
PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel)
Time frame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years
STENT THROMBOSIS
Time frame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years
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