Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02071342
Status:
UNKNOWN
Last Update Posted:
2014-02-25
First Post:
2014-01-02
Brief Title:
Study of ABSORB Stent in Acute Myocardial Infarction
Sponsor:
Umberto I Hospital Frosinone Italy
Organization:
Umberto I Hospital Frosinone Italy
Study Overview
Official Title:
Study of ABSORB Stent in Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2014-02
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:
ABSORB-ACS
Brief Summary:
The aim of our study is to evaluate the clinical outcomes at 30 days and 1 year cardiac death myocardial infarction target lesion revascularization TLR target vessel revascularization TVR thrombosis of the device in patients who are undergoing angioplasty in myocardial infarction and in which bioabsorbable stent was implanted BVS Additionally we will evaluate the acute recoil after implantation of bioabsorbable stents A 24 months follow-up by means of coronary angiography accompanied by QCA and assessment with intracoronary ultrasound IVUS and VH virtual histology is scheduled
Detailed Description:
The drug -eluting stents drug eluting stents DES are currently used routinely in the course of coronary angioplasty percutaneous coronary intervention PCI and have significantly reduced the incidence of adverse events during follow-up in the medium and long term
However the persistence of the metal structure of these devices within the coronary artery over time adds no additional benefit but on the contrary it is potentially harmful because it may predispose to coronary thrombosis even after years of implantation can alter the structure of the vessel for remodeling phenomena can decrease a coronary vasomotion and reducing the possibilily of a future surgery The recent development of new devices such as bioabsorbable vascular scaffold BVS release of antiproliferative drug everolimus could provide new clinical advantages especially in patients who are revascularized during acute myocardial infarction These patients are at higher risk of MACE and stent thrombosis late
The aim of our study is to evaluate the clinical outcomes conventional to 30 days and 1 year such as cardiac death myocardial infarction target lesion revascularizationTLR target vessel revascularization TVR thrombosis of the device in patients who undergo angioplasty in the course of acute coronary syndrome and in which it was implanted bioabsorbable stent BVS The acute recoil after implantation of bioresorbable vascular scaffold will also be assessed Finally a follow-up of 24 months we will conduct by means of coronary angiography accompanied by QCA and IVUS with VH
However the persistence of the metal structure of these devices within the coronary artery over time adds no additional benefit but on the contrary it is potentially harmful because it may predispose to coronary thrombosis even after years of implantation can alter the structure of the vessel for remodeling phenomena can decrease a coronary vasomotion and reducing the possibilily of a future surgery The recent development of new devices such as bioabsorbable vascular scaffold BVS release of antiproliferative drug everolimus could provide new clinical advantages especially in patients who are revascularized during acute myocardial infarction These patients are at higher risk of MACE and stent thrombosis late
The aim of our study is to evaluate the clinical outcomes conventional to 30 days and 1 year such as cardiac death myocardial infarction target lesion revascularizationTLR target vessel revascularization TVR thrombosis of the device in patients who undergo angioplasty in the course of acute coronary syndrome and in which it was implanted bioabsorbable stent BVS The acute recoil after implantation of bioresorbable vascular scaffold will also be assessed Finally a follow-up of 24 months we will conduct by means of coronary angiography accompanied by QCA and IVUS with VH
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