The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions

August 22, 2012 updated by: Sahajanand Medical Technologies Pvt. Ltd.

A Prospective, Multinational Investigation of the Supralimus® Sirolimus-Eluting Stent for the Treatment of Unselected Patients With Coronary Lesions in the "Real- World" Clinical Practice

E-SERIES Registry evaluate the procedural and clinical outcomes of the Supralimus® SES in the treatment of unselected, high risk patients having coronary Artery blockage in the real world clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

E-SERIES Registry is Prospective, multinational (Asia, South America and Europe), non-randomized, post-marketing web-based registry.

For this Study Up to 100 clinical sites in Asia, South America and Europe. Patients "ALL COMERS" assigned for percutaneous coronary interventions who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with the Supralimus® SES.

All subjects who provided signed informed consent prior to procedure, and have at least one lesion in a major epicardial vessel or major branch (>2.25mm), and are suitable for percutaneous treatment including stenting procedure with the Supralimus® SES. There are no limit regarding the number of lesions and/or study stents to be used, and stenting technique will be left at the operator's discretion; however, it is recommended according to the BEST interventional practice according to the current guidelines.

All patients will undergo follow-up clinical evaluation at 1, 6, 12 and 24 months. Angiographic follow-up will be performed at 6 months in a subset of high risk lesions including bifurcations (first 100 lesions) and left main stem (first 100 lesions).

Study Type

Interventional

Enrollment (Actual)

1274

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05022-001
        • Hospital São Camilo
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29047-575
        • CIAS- Unimed Vitória
    • Goiás
      • Goiânia, Goiás, Brazil, 74823-320
        • Centro de Cardiologia e Radiologia
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-090
        • Hospital Luxemburgo
      • Juiz de Fora, Minas Gerais, Brazil, 36025-550
        • Hospital Monte Sinai
    • Paraná
      • Curitiba, Paraná, Brazil
        • Hospital Vita
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil
        • H.C.Unesp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. CLINICAL INCLUSION CRITERIA: Patients >18 years, clinical indication for elective or emergency percutaneous coronary intervention with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups.
  2. ANGIOGRAPHIC INCLUSION CRITERIA: Diseased coronary vessels with at least one lesion with ≥50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (>2.25mm) with anatomy suitable for percutaneous treatment with the Supralimus SES.

Exclusion Criteria:

  1. CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
  2. ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supralimus® Sirolimus-Eluting Coronary Stent
Device: Supralimus® Sirolimus-Eluting Coronary 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
Other Names:
  • Drug Eluting Stent (DES)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of procedural success
Time Frame: 24 month
24 month
Rates of Major Adverse Cardiac Event (MACE)
Time Frame: In-hospital, 30 days, 6 and 24 months
In-hospital, 30 days, 6 and 24 months
Rates of target lesion revascularization (TLR)
Time Frame: 6 and 12 months
6 and 12 months
Rates of stent thrombosis (acute, sub-acute, late and very-late)
Time Frame: Up to 24 months follow-up
Up to 24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahajanand Medical Technologies Pvt. Ltd.

Collaborators

Cardiovascular Research Center, Brazil

Investigators

  • Principal Investigator: Alexandre Abizaid,, MD, Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 2.0 (Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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