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

NCT00917163 | Terminated Phase 4 DMC

• 1 other identifier: SES/RCT/01
• Study Type: interventional
• Target: 13
• Locations: 3 countries
• Sites: 28

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™.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; restenosis; stent thrombosis; coronary stents; angioplasty; drug eluting stents

Outcome Measures

Primary Outcomes (1)

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

  9 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Supralimus(R) Sirolimus Eluting Stent

EXPERIMENTAL

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

Xience V™ Everolimus Eluting Stent

ACTIVE COMPARATOR

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

Interventions

Supralimus(R) Sirolimus-Eluting Coronary Stent System DEVICE

Drug eluting stent implantation in the treatment of coronary artery disease.

Also known as: Drug Eluting Stent

Supralimus(R) Sirolimus Eluting Stent

Xience V™ Everolimus Eluting Coronary Stent DEVICE

Drug eluting stent implantation in the treatment of coronary artery disease

Also known as: Drug Eluting Stent

Xience V™ Everolimus Eluting Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Eligible for percutaneous coronary intervention (PCI)
• Acceptable candidate for CABG
• 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.

You may not qualify if:

• The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
• The target lesion must be ≤ 22 mm in length by visual estimate.
• The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
• 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.
• Female of childbearing potential
• Documented left ventricular ejection fraction (LVEF) ≤ 30%
• Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
• 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)
• A platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3
• Acute or chronic renal dysfunction (creatinine \>2.0mg/dl or \>150µmol/L)
• Total occlusion (TIMI 0) or TIMI 1
• Target vessel has evidence of thrombus
• Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
• Previous bare metal stenting (less than 1 year) anywhere within the target vessel
• Previous drug-eluting stenting anywhere within any epicardial vessel

Sponsors & Collaborators

• Sahajanand Medical Technologies Limited: lead
• Cardialysis BV: collaborator

Study Sites (28)

Incor Hospital

Brasília, Brasília, 70658-700, Brazil

Location

Hospital Meridional

Vitaria, Espírito Santo, 29156-580, Brazil

Location

Centro de Cardiologia e Radiologia Intervencionista

Goiânia, Goiás, 74823-470, Brazil

Location

Cardiovascular Diagnóstico

Campo Grande, Mato Grosso do Sul, 79002-250, Brazil

Location

Santa Casa de misericórdia de Juiz de fora

Juiz de Fora, Minas Gerais, 36025-040, Brazil

Location

Intistuto do Coracao do Triangulo

Uberlândia, Minas Gerais, 38400-299, Brazil

Location

Hospital Costantino Constantini

Curitiba, Paraná, 80320-320, Brazil

Location

Instituto de Cardiologia

São Paulo, São Paulo, 01323-900, Brazil

Location

Hospital Bandeirantes

São Paulo, São Paulo, 01506-000, Brazil

Location

Incor Hospital

São Paulo, São Paulo, 04012-180, Brazil

Location

Instituto Dante Pazzanese

São Paulo, São Paulo, 04012-180, Brazil

Location

Hospital Albert Einstein

São Paulo, São Paulo, 05651-901, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

Life Care Institute

Ahmedabad, Gujarat, 380014, India

Location

Shri.Jayadeva Institute of Cardiology

Bangalore, Karnataka, 560069, India

Location

P.R.S Hospital

Trivandrum, Kerala, 695002, India

Location

Jaslok Hospital & Research Centre

Mumbai, Maharashtra, 400 026, India

Location

KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Escorts Heart Institute & Research Centre

New Delhi, National Capital Territory of Delhi, 110 025, India

Location

Max Devki Devi Heart and Vascular Institute

New Delhi, National Capital Territory of Delhi, 110017, India

Location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Apollo Hospital

Chennai, Tamil Nadu, 600 006, India

Location

Madras Medical Mission

Chennai, Tamil Nadu, 600037, India

Location

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226 014, India

Location

Kailash Health Care Limited

Noida, Uttar Pradesh, 201 301, India

Location

B.M.Birla Heart Research Center

Kolkata, West Bengal, 700 027, India

Location

KAUH King Abdl Aziz University Hospital

Jeddah, 21589, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 19112780 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Prof. Patrick W Serruys, MD, Ph.D

  Thoraxcenter,Rotterdam,NL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

BR (13); IN (14); SA (1)