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

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System; Device: Xience V™ Everolimus Eluting Coronary Stent

• Registration Number: NCT00917163
• Lead Sponsor: Sahajanand Medical Technologies Limited

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.

Study Timeline

• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Study Start: 2009-07
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supralimus(R) Sirolimus Eluting Stent	Supralimus(R) Sirolimus-Eluting Coronary Stent System	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
Xience V™ Everolimus Eluting Stent	Xience V™ Everolimus Eluting Coronary Stent	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

Primary Outcome Measures

Name	Time	Method
In-stent luminal late loss at 9 months after stent implantation (off-line QCA).	9 months

Secondary Outcome Measures

Name	Time	Method
PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate	Hospital discharge
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
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
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

Trial Locations

Locations (27)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India

Escorts Heart Institute & Research Centre; 🇮🇳 New Delhi, Delhi, India

Max Devki Devi Heart and Vascular Institute; 🇮🇳 New Delhi, Delhi, India

Cardiovascular Diagnóstico; 🇧🇷 Campo Grande, Mato Grosso do Sul, Brazil

Santa Casa de misericórdia de Juiz de fora; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil

Intistuto do Coracao do Triangulo; 🇧🇷 Uberlandia, Minas Gerais, Brazil

Madras Medical Mission; 🇮🇳 Chennai, Tamil Nadu, India

Hospital Albert Einstein; 🇧🇷 Sao Paulo, Brazil

Kailash Health Care Limited; 🇮🇳 Noida, Uttar Pradesh, India

Instituto de Cardiologia; 🇧🇷 Sao Paulo, Brazil

Hospital Santa Marcelina; 🇧🇷 Sao Paulo, Brazil

P.R.S Hospital; 🇮🇳 Trivandrum, Kerala, India

Life Care Institute; 🇮🇳 Ahmedabad, Gujarat, India

Incor Hospital; 🇧🇷 Sao Paulo, Brazil

Jaslok Hospital & Research Centre; 🇮🇳 Mumbai, Maharashtra, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, Uttar Pradesh, India

Instituto Dante Pazzanese; 🇧🇷 Sao Paulo, Brazil

Hospital Costantino Constantini; 🇧🇷 Curitiba, Paraná, Brazil

Hospital Meridional; 🇧🇷 Vitaria, Espirito Santo, Brazil

Centro de Cardiologia e Radiologia Intervencionista; 🇧🇷 Goiania, Goiás., Brazil

Hospital Bandeirantes; 🇧🇷 Sao Paulo, Brazil

Shri.Jayadeva Institute of Cardiology; 🇮🇳 Bangalore, Karnataka, India

Apollo Hospital; 🇮🇳 Chennai, Tamilnadu, India

B.M.Birla Heart Research Center; 🇮🇳 Kolkata, West Bengal, India

KAUH King Abdl Aziz University Hospital; 🇸🇦 Jeddah, Saudi Arabia

KEM Hospital; 🇮🇳 Mumbai, Maharashtra, India

Ruby Hall Clinic; 🇮🇳 Pune, Maharashtra, India