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

A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

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™.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System; Device: Xience V™ Everolimus Eluting Coronary Stent

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Brasília, Brazil, 70658-700
    • Incor Hospital
  • Sao Paulo, Brazil, 01323-900
    • Instituto de Cardiologia
  • Sao Paulo, Brazil, 01506-000
    • Hospital Bandeirantes
  • Sao Paulo, Brazil, 04012-180
    • Incor Hospital
  • Sao Paulo, Brazil, 04012-180
    • Instituto Dante Pazzanese
  • Sao Paulo, Brazil, 05651-901
    • Hospital Albert Einstein
  • Sao Paulo, Brazil, 08270-070
    • Hospital Santa Marcelina
  • Espirito Santo
    • Vitaria, Espirito Santo, Brazil, 29156-580
      • Hospital Meridional
  • Goiás.
    • Goiania, Goiás., Brazil, 74823-470
      • Centro de Cardiologia e Radiologia Intervencionista
  • Mato Grosso do Sul
    • Campo Grande, Mato Grosso do Sul, Brazil, 79002-250
      • Cardiovascular Diagnóstico
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36025-040
      • Santa Casa de Misericórdia de Juiz de Fora
    • Uberlandia, Minas Gerais, Brazil, 38400-299
      • Intistuto do Coracao do Triangulo
  • Paraná
    • Curitiba, Paraná, Brazil, 80320-320
      • Hospital Costantino Constantini
• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences
    • New Delhi, Delhi, India, 110 025
      • Escorts Heart Institute & Research Centre
    • New Delhi, Delhi, India, 110017
      • Max Devki Devi Heart and Vascular Institute
  • Gujarat
    • Ahmedabad, Gujarat, India, 380014
      • Life Care Institute
  • Karnataka
    • Bangalore, Karnataka, India, 560069
      • Shri.Jayadeva Institute of Cardiology
  • Kerala
    • Trivandrum, Kerala, India, 695002
      • P.R.S Hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • KEM Hospital
    • Mumbai, Maharashtra, India, 400 026
      • Jaslok Hospital & Research Centre
    • Pune, Maharashtra, India, 411001
      • Ruby Hall Clinic
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600037
      • Madras Medical Mission
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600 006
      • Apollo Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 014
      • Sanjay Gandhi Post Graduate Institute of Medical Sciences
    • Noida, Uttar Pradesh, India, 201 301
      • Kailash Health Care Limited
  • West Bengal
    • Kolkata, West Bengal, India, 700 027
      • B.M.Birla Heart Research Center
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21589
    • KAUH King Abdl Aziz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supralimus(R) Sirolimus Eluting Stent; 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	Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System; Drug eluting stent implantation in the treatment of coronary artery disease.; Other Names: Drug Eluting Stent
Active Comparator: Xience V™ Everolimus Eluting 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	Device: Xience V™ Everolimus Eluting Coronary Stent; Drug eluting stent implantation in the treatment of coronary artery disease; Other Names: Drug Eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent luminal late loss at 9 months after stent implantation (off-line QCA).	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Pvt. Ltd.
• Collaborators: Cardialysis BV
• Investigators: Study Chair: Prof. Patrick W Serruys, MD, Ph.D, Thoraxcenter,Rotterdam,NL

Publications and helpful links

General Publications

• Dani S, Kukreja N, Parikh P, Joshi H, Prajapati J, Jain S, Thanvi S, Shah B, Dutta JP. Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study. EuroIntervention. 2008 May;4(1):59-63. doi: 10.4244/eijv4i1a11.
• Dr. A.Abhyankar; Evaluation of Safety, Efficacy and Procedural Outcomes of Extra Long Sirolimus Eluting Stent with novel polymeric technology for treatment of long de novo coronary lesions; Catheterization Cardiovascular Interventions; 3rd Nov - 2nd Dec 2006; DOI 10.1002/ccd.21033

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: coronary artery disease; angioplasty; drug eluting stents; stent thrombosis; restenosis; coronary stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Everolimus; Sirolimus
• Other Study ID Numbers: SES/RCT/01