The E-SERIES Registry for Supralimus® Coronary Stent for... | NCT01368627

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 7, 2011

First Submission Date that Met QC Criteria

Jun 7, 2011

First Posted Date

Jun 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2012

Last Update Posted Date

Aug 23, 2012Estimated

Name	Class
Cardiovascular Research Center, Brazil	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supralimus® Sirolimus-Eluting Coronary Stent	Experimental		Device: Supralimus® Sirolimus-Eluting Coronary Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supralimus® Sirolimus-Eluting Coronary Stent	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MAJOR ADVERSE CARDIAC EVENTS (MACE)		12 months

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Abizaid,, MD	Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CIAS- Unimed Vitória		Vitória	Espírito Santo	29047-575	Brazil
Centro de Cardiologia e Radiologia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D015607	Stents
D019736	Prostheses and Implants
D004864	Equipment and Supplies