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

This study has been completed.
Sponsor:
Collaborator:
Cardiovascular Research Center, Brazil
Information provided by (Responsible Party):
Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01368627
First received: June 7, 2011
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Supralimus® Sirolimus-Eluting Coronary Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sahajanand Medical Technologies Pvt. Ltd.:

Primary Outcome Measures:
  • MAJOR ADVERSE CARDIAC EVENTS (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rates of procedural success [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Rates of Major Adverse Cardiac Event (MACE) [ Time Frame: In-hospital, 30 days, 6 and 24 months ] [ Designated as safety issue: Yes ]
  • Rates of target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Rates of stent thrombosis (acute, sub-acute, late and very-late) [ Time Frame: Up to 24 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 1274
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Drug Eluting Stent (DES)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368627

Locations
Brazil
CIAS- Unimed Vitória
Vitória, Espírito Santo, Brazil, 29047-575
Centro de Cardiologia e Radiologia
Goiânia, Goiás, Brazil, 74823-320
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, Brazil, 30380-090
Hospital Monte Sinai
Juiz de Fora, Minas Gerais, Brazil, 36025-550
Hospital Vita
Curitiba, Paraná, Brazil
H.C.Unesp
Botucatu, Sao Paulo, Brazil
Hospital São Camilo
São Paulo, Brazil, 05022-001
Sponsors and Collaborators
Sahajanand Medical Technologies Pvt. Ltd.
Cardiovascular Research Center, Brazil
Investigators
Principal Investigator: Alexandre Abizaid,, MD Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
  More Information

Additional Information:
No publications provided

Responsible Party: Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01368627     History of Changes
Other Study ID Numbers: Version 2.0
Study First Received: June 7, 2011
Last Updated: August 22, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.:
Coronary Artery Disease
Restenosis
Stent thrombosis
Coronary stents
Angioplasty
Drug Eluting Stents(DES)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014