NCT01368627

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,274 (actual)
• Sponsor: Sahajanand Medical Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-06-08
• Last updated: 2012-08-23

Locations

7 sites across 1 country: Brazil