SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent
NCT ID: NCT00917163
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
13 participants
INTERVENTIONAL
2009-07-31
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Supralimus(R) Sirolimus-Eluting Coronary Stent System
Drug eluting stent implantation in the treatment of coronary artery disease.
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
Xience V™ Everolimus Eluting Coronary Stent
Drug eluting stent implantation in the treatment of coronary artery disease
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supralimus(R) Sirolimus-Eluting Coronary Stent System
Drug eluting stent implantation in the treatment of coronary artery disease.
Xience V™ Everolimus Eluting Coronary Stent
Drug eluting stent implantation in the treatment of coronary artery disease
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardialysis BV
INDUSTRY
Sahajanand Medical Technologies Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Patrick W Serruys, MD, Ph.D
Role: STUDY_CHAIR
Thoraxcenter,Rotterdam,NL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Incor Hospital
Brasília, Brasília, Brazil
Hospital Meridional
Vitaria, Espírito Santo, Brazil
Centro de Cardiologia e Radiologia Intervencionista
Goiânia, Goiás, Brazil
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
Uberlândia, Minas Gerais, Brazil
Hospital Costantino Constantini
Curitiba, Paraná, Brazil
Instituto de Cardiologia
São Paulo, São Paulo, Brazil
Hospital Bandeirantes
São Paulo, São Paulo, Brazil
Incor Hospital
São Paulo, São Paulo, Brazil
Instituto Dante Pazzanese
São Paulo, São Paulo, Brazil
Hospital Albert Einstein
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
Life Care Institute
Ahmedabad, Gujarat, India
Shri.Jayadeva Institute of Cardiology
Bangalore, Karnataka, India
P.R.S Hospital
Trivandrum, Kerala, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India
KEM Hospital
Mumbai, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Escorts Heart Institute & Research Centre
New Delhi, National Capital Territory of Delhi, India
Max Devki Devi Heart and Vascular Institute
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Apollo Hospital
Chennai, Tamil Nadu, India
Madras Medical Mission
Chennai, Tamil Nadu, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Kailash Health Care Limited
Noida, Uttar Pradesh, India
B.M.Birla Heart Research Center
Kolkata, West Bengal, India
KAUH King Abdl Aziz University Hospital
Jeddah, , Saudi Arabia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SES/RCT/01
Identifier Type: -
Identifier Source: org_study_id