The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Supralimus® Sirolimus-Eluting Coronary Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Restenosis, Stent thrombosis, Coronary stents, Angioplasty, Drug Eluting Stents(DES)
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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:
- CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
- ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
Sites / Locations
- CIAS- Unimed Vitória
- Centro de Cardiologia e Radiologia
- Hospital Luxemburgo
- Hospital Monte Sinai
- Hospital Vita
- H.C.Unesp
- Hospital São Camilo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supralimus® Sirolimus-Eluting Coronary Stent
Arm Description
Outcomes
Primary Outcome Measures
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Secondary Outcome Measures
Rates of procedural success
Rates of Major Adverse Cardiac Event (MACE)
Rates of target lesion revascularization (TLR)
Rates of stent thrombosis (acute, sub-acute, late and very-late)
Full Information
NCT ID
NCT01368627
First Posted
June 7, 2011
Last Updated
August 22, 2012
Sponsor
Sahajanand Medical Technologies Limited
Collaborators
Cardiovascular Research Center, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01368627
Brief Title
The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sahajanand Medical Technologies Limited
Collaborators
Cardiovascular Research Center, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Restenosis, Stent thrombosis, Coronary stents, Angioplasty, Drug Eluting Stents(DES)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supralimus® Sirolimus-Eluting Coronary Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Supralimus® Sirolimus-Eluting Coronary Stent
Other Intervention Name(s)
Drug Eluting Stent (DES)
Intervention Description
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
Primary Outcome Measure Information:
Title
MAJOR ADVERSE CARDIAC EVENTS (MACE)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rates of procedural success
Time Frame
24 month
Title
Rates of Major Adverse Cardiac Event (MACE)
Time Frame
In-hospital, 30 days, 6 and 24 months
Title
Rates of target lesion revascularization (TLR)
Time Frame
6 and 12 months
Title
Rates of stent thrombosis (acute, sub-acute, late and very-late)
Time Frame
Up to 24 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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:
CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Abizaid,, MD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIAS- Unimed Vitória
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29047-575
Country
Brazil
Facility Name
Centro de Cardiologia e Radiologia
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74823-320
Country
Brazil
Facility Name
Hospital Luxemburgo
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30380-090
Country
Brazil
Facility Name
Hospital Monte Sinai
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36025-550
Country
Brazil
Facility Name
Hospital Vita
City
Curitiba
State/Province
Paraná
Country
Brazil
Facility Name
H.C.Unesp
City
Botucatu
State/Province
Sao Paulo
Country
Brazil
Facility Name
Hospital São Camilo
City
São Paulo
ZIP/Postal Code
05022-001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
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