Coronary Artery Disease
Conditions
Keywords
coronary artery disease, restenosis, stent thrombosis, coronary stents, angioplasty, drug eluting stents
Brief summary
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™.
Detailed description
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.
Interventions
DEVICESupralimus(R) Sirolimus-Eluting Coronary Stent System
Drug eluting stent implantation in the treatment of coronary artery disease.
DEVICEXience V™ Everolimus Eluting Coronary Stent
Drug eluting stent implantation in the treatment of coronary artery disease
Sponsors
Cardialysis BV
Sahajanand Medical Technologies Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Eligible for percutaneous coronary intervention (PCI) 3. Acceptable candidate for CABG 4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia. 5. The target lesion is a single de novo coronary artery lesion with ≥ 50% and \< 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/
Exclusion criteria
and will receive the same type of stent. 6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion. 7. The target lesion must be ≤ 22 mm in length by visual estimate. 8. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm. 9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent luminal late loss at 9 months after stent implantation (off-line QCA). | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate | 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 | 9 months |
| PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate | Hospital discharge |
| PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel) | 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years |
| STENT THROMBOSIS | 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years |
| DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR) | 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years |
Countries
Brazil, India, Saudi Arabia
Outcome results
None listed