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

Sponsor
Sahajanand Medical Technologies Pvt. Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00917163
Collaborator
Cardialysis BV (Industry)
13
Enrollment
28
Locations
2
Arms
10
Duration (Months)
0.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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™.

Condition or Disease Intervention/Treatment Phase
  • Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System
  • Device: Xience V™ Everolimus Eluting Coronary Stent
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. In-stent luminal late loss at 9 months after stent implantation (off-line QCA). [9 months]

    Secondary Outcome Measures

    1. PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate [Hospital discharge]

    2. ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate [9 months]

    3. 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]

    4. 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]

    5. 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]

    6. STENT THROMBOSIS [30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Sahajanand Medical Technologies Pvt. Ltd.
    • Cardialysis BV

    Investigators

    • Study Chair: Prof. Patrick W Serruys, MD, Ph.D, Thoraxcenter,Rotterdam,NL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sahajanand Medical Technologies Pvt. Ltd.
    ClinicalTrials.gov Identifier:
    NCT00917163
    Other Study ID Numbers:
    • SES/RCT/01
    First Posted:
    Jun 10, 2009
    Last Update Posted:
    Aug 23, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.
    coronary artery disease
    restenosis
    stent thrombosis
    coronary stents
    angioplasty
    drug eluting stents
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Sirolimus
    Everolimus

    Study Results

    No Results Posted as of Aug 23, 2012