The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Supralimus® Sirolimus-Eluting Coronary Stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- MAJOR ADVERSE CARDIAC EVENTS (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Rates of procedural success [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
- Rates of Major Adverse Cardiac Event (MACE) [ Time Frame: In-hospital, 30 days, 6 and 24 months ] [ Designated as safety issue: Yes ]
- Rates of target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Rates of stent thrombosis (acute, sub-acute, late and very-late) [ Time Frame: Up to 24 months follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 1274 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Supralimus® Sirolimus-Eluting Coronary Stent |
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
Other Name: Drug Eluting Stent (DES)
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Brazil | |
| CIAS- Unimed Vitória | |
| Vitória, Espírito Santo, Brazil, 29047-575 | |
| Centro de Cardiologia e Radiologia | |
| Goiânia, Goiás, Brazil, 74823-320 | |
| Hospital Luxemburgo | |
| Belo Horizonte, Minas Gerais, Brazil, 30380-090 | |
| Hospital Monte Sinai | |
| Juiz de Fora, Minas Gerais, Brazil, 36025-550 | |
| Hospital Vita | |
| Curitiba, Paraná, Brazil | |
| H.C.Unesp | |
| Botucatu, Sao Paulo, Brazil | |
| Hospital São Camilo | |
| São Paulo, Brazil, 05022-001 | |
| Principal Investigator: | Alexandre Abizaid,, MD | Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sahajanand Medical Technologies Pvt. Ltd. |
| ClinicalTrials.gov Identifier: | NCT01368627 History of Changes |
| Other Study ID Numbers: | Version 2.0 |
| Study First Received: | June 7, 2011 |
| Last Updated: | August 22, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.:
|
Coronary Artery Disease Restenosis Stent thrombosis |
Coronary stents Angioplasty Drug Eluting Stents(DES) |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 17, 2013