Clinical trial NCT01368627: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Restenosis
Stent thrombosis
Coronary stents
Angioplasty
Drug Eluting Stents(DES)
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: Cardiovascular Research Center, Brazil
First posted: 2011-06-08
Enrollment: 1274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: MAJOR ADVERSE CARDIAC EVENTS (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Rates of procedural success
timeFrame: 24 month
measure: Rates of Major Adverse Cardiac Event (MACE)
timeFrame: In-hospital, 30 days, 6 and 24 months
measure: Rates of target lesion revascularization (TLR)
timeFrame: 6 and 12 months
measure: Rates of stent thrombosis (acute, sub-acute, late and very-late)
timeFrame: Up to 24 months follow-up
Other outcomes:
Locations:
city: Vitória
country: Brazil
facility: CIAS- Unimed Vitória
state: Espírito Santo
city: Goiânia
country: Brazil
facility: Centro de Cardiologia e Radiologia
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Hospital Luxemburgo
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: Hospital Monte Sinai
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Vita
state: Paraná
city: Botucatu
country: Brazil
facility: H.C.Unesp
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital São Camilo
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
name: Alexandre Abizaid,, MD
role: PRINCIPAL_INVESTIGATOR
References: