Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02247492
Status:
UNKNOWN
Last Update Posted:
2018-07-23
First Post:
2014-09-17
Brief Title:
BIOFLOW-III VIP Russia Registry Orsiro Stent System
Sponsor:
Biotronik Russia
Organization:
Biotronik Russia
Study Overview
Official Title:
BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III and Vulnerable Inflammation Parameter Registry
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents DES Along with it an explanatory hypothesis-finding problem will be investigated whether the patients body inflammation status correlates with the clinical outcome
Detailed Description:
For the majority of Coronary Artery Disease CAD treatment with Percutaneous Transluminal Coronary Angioplasty PTCA provides high initial procedure success However the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing The reported incidence of restenosis after PTCA ranges from 30 to 50 Such rates of recurrence have serious economic consequences Bare Metal Stents BMS designed to address the limitations of PTCA reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG BMS substantially reduced the incidence of abrupt artery closure but restenosis still occurred in about 20 to 40 of cases necessitating repeat procedures
The invention of Drug Eluting Stents DES significantly improved on the principle of BMS by adding an antiproliferative drug directly immobilized on the stent surface or released from a polymer matrix which inhibits neointimal hyperplasia The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice
Along with it an explanatory hypothesis-finding problem will be investigated whether the patients body inflammation status correlates with the clinical outcome
The invention of Drug Eluting Stents DES significantly improved on the principle of BMS by adding an antiproliferative drug directly immobilized on the stent surface or released from a polymer matrix which inhibits neointimal hyperplasia The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice
Along with it an explanatory hypothesis-finding problem will be investigated whether the patients body inflammation status correlates with the clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None