AzTrials
AzTrials

Coronary Artery DiseasePhase 4NCT00917163

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

A Phase 4 study testing Supralimus(R) Sirolimus-Eluting Coronary Stent System and Xience V™ Everolimus Eluting Coronary Stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 28 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Supralimus(R) Sirolimus-Eluting Coronary Stent System and Xience V™ Everolimus Eluting Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
28 sitesin 3 countries
Study dates
Jul 2009to May 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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)
Show all 25Show fewer
  • 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
  • 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.)
  • Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
  • Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • Ostial target lesion
  • Target lesion involves a side branch >2.0mm in diameter with an ostial disease
  • Patient is currently participating in an investigational drug or device study, including its follow-up period
  • Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
  • 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.
  • Stroke or transient ischemic attack within the prior 6 months
  • Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
  • 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
  • Planned surgery within 6 months after the index procedure
  • Life expectancy less than 1 year

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

India14 sites

  • Life Care Institute

    Ahmedabad, Gujarat, 380014

  • Shri.Jayadeva Institute of Cardiology

    Bangalore, Karnataka, 560069

  • Apollo Hospital

    Chennai, Tamil Nadu, 600 006

  • Madras Medical Mission

    Chennai, Tamil Nadu, 600037

  • B.M.Birla Heart Research Center

    Kolkata, West Bengal, 700 027

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226 014

  • Jaslok Hospital & Research Centre

    Mumbai, Maharashtra, 400 026

  • KEM Hospital

    Mumbai, Maharashtra, 400012

  • Escorts Heart Institute & Research Centre

    New Delhi, National Capital Territory of Delhi, 110 025

  • Max Devki Devi Heart and Vascular Institute

    New Delhi, National Capital Territory of Delhi, 110017

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Kailash Health Care Limited

    Noida, Uttar Pradesh, 201 301

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • P.R.S Hospital

    Trivandrum, Kerala, 695002

Other trials in India

Brazil13 sites

  • Incor Hospital

    Brasília, Brasília, 70658-700

  • Cardiovascular Diagnóstico

    Campo Grande, Mato Grosso do Sul, 79002-250

  • Hospital Costantino Constantini

    Curitiba, Paraná, 80320-320

  • Centro de Cardiologia e Radiologia Intervencionista

    Goiânia, Goiás, 74823-470

  • Santa Casa de misericórdia de Juiz de fora

    Juiz de Fora, Minas Gerais, 36025-040

  • Instituto de Cardiologia

    São Paulo, São Paulo, 01323-900

  • Hospital Bandeirantes

    São Paulo, São Paulo, 01506-000

  • Incor Hospital

    São Paulo, São Paulo, 04012-180

  • Instituto Dante Pazzanese

    São Paulo, São Paulo, 04012-180

  • Hospital Albert Einstein

    São Paulo, São Paulo, 05651-901

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08270-070

  • Intistuto do Coracao do Triangulo

    Uberlândia, Minas Gerais, 38400-299

  • Hospital Meridional

    Vitaria, Espírito Santo, 29156-580

Other trials in Brazil

Saudi Arabia1 site

  • KAUH King Abdl Aziz University Hospital

    Jeddah, 21589

Other trials in Saudi Arabia

About this study

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

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™.

Read the 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.

Being tested
Supralimus(R) Sirolimus-Eluting Coronary Stent System, Xience V™ Everolimus Eluting Coronary Stent
Keywords
coronary artery disease, restenosis, stent thrombosis, coronary stents, angioplasty, drug eluting stents
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supralimus(R) Sirolimus-Eluting Coronary Stent SystemDevice

    Also called Drug Eluting Stent

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

  • Xience V™ Everolimus Eluting Coronary StentDevice

    Also called Drug Eluting Stent

    Drug eluting stent implantation in the treatment of coronary artery disease

Study groups in NCT00917163
Study groupRoleWhat they receive
Supralimus(R) Sirolimus Eluting StentExperimentalSupralimus® 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
Receives: Device: Supralimus(R) Sirolimus-Eluting Coronary Stent System
Xience V™ Everolimus Eluting StentActive comparatorThe 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
Receives: Device: Xience V™ Everolimus Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 9 months

Secondary outcomes (6)

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

    Measured: Hospital discharge

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

    Measured: 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

    Measured: 9 months

  4. DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR)

    Measured: 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)

    Measured: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years

  6. STENT THROMBOSIS

    Measured: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionMay 2010
  4. Study completionMay 2010

Why it stopped: due to unavoidable circumstances relating to logistic issues and regulatory processes in various countries causing unacceptable delays.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00917163
Sponsor's protocol ID
SES/RCT/01
Status last verified
Aug 2012
First submitted
8 Jun 2009
Last updated
23 Aug 2012
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 19112780

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Supralimus(R) Sirolimus-Eluting Coronary Stent System and Xience V™ Everolimus Eluting Coronary Stent in people with Coronary Artery Disease, run by Sahajanand Medical Technologies Limited at 28 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in India, Brazil, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: due to unavoidable circumstances relating to logistic issues and regulatory processes in various countries causing unacceptable delays.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent luminal late loss at 9 months after stent implantation (off-line QCA). (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00917163, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in