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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368627
• Other study ID #: Version 2.0
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2011
• Last updated: August 22, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Sahajanand Medical Technologies Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1274
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Luxemburgo	Belo Horizonte	Minas Gerais
Brazil	H.C.Unesp	Botucatu	Sao Paulo
Brazil	Hospital Vita	Curitiba	Paraná
Brazil	Centro de Cardiologia e Radiologia	Goiânia	Goiás
Brazil	Hospital Monte Sinai	Juiz de Fora	Minas Gerais
Brazil	Hospital São Camilo	São Paulo
Brazil	CIAS- Unimed Vitória	Vitória	Espírito Santo

Sponsors (2)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Pvt. Ltd.	Cardiovascular Research Center, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAJOR ADVERSE CARDIAC EVENTS (MACE)		12 months	Yes
Secondary	Rates of procedural success		24 month	Yes
Secondary	Rates of Major Adverse Cardiac Event (MACE)		In-hospital, 30 days, 6 and 24 months	Yes
Secondary	Rates of target lesion revascularization (TLR)		6 and 12 months	No
Secondary	Rates of stent thrombosis (acute, sub-acute, late and very-late)		Up to 24 months follow-up	Yes