SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent

Sahajanand Medical Technologies

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System; Device: Xience V™ Everolimus Eluting Coronary Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917163

SES/RCT/01

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

1. Female of childbearing potential
2. Documented left ventricular ejection fraction (LVEF) ≤ 30%
3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated)
5. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3
6. Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)
7. Total occlusion (TIMI 0) or TIMI 1
8. Target vessel has evidence of thrombus
9. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
10. Previous bare metal stenting (less than 1 year) anywhere within the target vessel
11. Previous drug-eluting stenting anywhere within any epicardial vessel
12. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
13. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. Ostial target lesion
17. Target lesion involves a side branch >2.0mm in diameter with an ostial disease
18. Patient is currently participating in an investigational drug or device study, including its follow-up period
19. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
20. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
21. Stroke or transient ischemic attack within the prior 6 months
22. Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
23. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
24. Planned surgery within 6 months after the index procedure
25. Life expectancy less than 1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Supralimus(R) Sirolimus Eluting Stent

Experimental group

Description:

Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2

Treatment:

Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System

Xience V™ Everolimus Eluting Stent

Active Comparator group

Description:

The XIENCE V™ Everolimus Eluting Coronary Stent System consisting of the MULTI-LINK VISION® Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a non-erodible polymer., Drug Load: 100 µg/cm2

Treatment:

Device: Xience V™ Everolimus Eluting Coronary Stent