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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Supralimus® Sirolimus-Eluting Coronary Stent

• Registration Number: NCT01368627
• Lead Sponsor: Sahajanand Medical Technologies Limited

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).

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1274

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supralimus® Sirolimus-Eluting Coronary Stent	Supralimus® Sirolimus-Eluting Coronary Stent	-

Primary Outcome Measures

Name	Time	Method
MAJOR ADVERSE CARDIAC EVENTS (MACE)	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (7)

CIAS- Unimed Vitória; 🇧🇷 Vitória, Espírito Santo, Brazil

H.C.Unesp; 🇧🇷 Botucatu, Sao Paulo, Brazil

Hospital Monte Sinai; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil

Hospital Luxemburgo; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Vita; 🇧🇷 Curitiba, Paraná, Brazil

Hospital São Camilo; 🇧🇷 São Paulo, Brazil

Centro de Cardiologia e Radiologia; 🇧🇷 Goiânia, Goiás, Brazil