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

This study has been terminated.
(due to unavoidable circumstances relating to logistic issues and regulatory processes in various countries causing unacceptable delays.)
Sponsor:
Collaborator:
Cardialysis BV
Information provided by (Responsible Party):
Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT00917163
First received: June 8, 2009
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System
Device: Xience V™ Everolimus Eluting Coronary Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Sahajanand Medical Technologies Pvt. Ltd.:

Primary Outcome Measures:
  • In-stent luminal late loss at 9 months after stent implantation (off-line QCA). [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]
  • ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR) [ Time Frame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
  • PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel) [ Time Frame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]
  • STENT THROMBOSIS [ Time Frame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Drug Eluting 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917163

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

Additional Information:
Publications:
Dr. Sameer Dani; 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;4:59-63

Responsible Party: Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT00917163     History of Changes
Other Study ID Numbers: SES/RCT/01
Study First Received: June 8, 2009
Last Updated: August 22, 2012
Health Authority: Brazil: National Health Surveillance Agency
India: Drugs Controller General of India
Saudi Arabia: Ministry of Health

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
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014