Study of ABSORB Stent in Acute Myocardial Infarction (ABSORB-ACS)
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.
Acute Myocardial Infarction
Artery; Deformity, Coronary (Acquired)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study of ABSORB Stent in Acute Coronary Syndrome|
- MACE (Death, MI, TLR and TVR) [ Time Frame: One year after index procedure ] [ Designated as safety issue: Yes ]MACE at 30 days and 1 year (Death, MI, TLR and TVR) and thrombosis of the device in patients with acute coronary syndrome undergoing PCI with stenting bioresorbable
- Acute stent Recoil [ Time Frame: Within ten minutes after scaffold implantation ] [ Designated as safety issue: Yes ]Evaluation of acute recoil after implantation of bioabsorbable stent (BVS).
- conformability [ Time Frame: immediately after implantation of the device ] [ Designated as safety issue: Yes ]Evaluation of the conformability of the stent and the vessel curvature and angle before and after implantation of the device
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
acute coronary syndrome
patients with acute myocardial infarction who are undergoing coronary angioplasty. MACE at 30 days and 1 year will be assessed . The acute recoil after implantation of bioabsorbable stents will also be assessed
patients with acute coronary syndrome and coronary angioplasty with bioresorbable vascular scaffold.
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 revascularization(TLR ), 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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT02071342
|Contact: Maurizio Menichelli, MDemail@example.com|
|Division of interventional cardiology, Umberto I Hospital||Recruiting|
|Frosinone, Italy, 030100|
|Contact: Maurizio Menichelli, MD +39 3382642317 firstname.lastname@example.org|
|Sub-Investigator: Giancarlo Di Ruzza, MD|
|Sub-Investigator: Pasquale Mollo, MD|
|Sub-Investigator: Duino Boncompagni, MD|
|Sub-Investigator: Marco Cesario, MD|
|Sub-Investigator: Andrea Mazza, MD|
|Principal Investigator:||Maurizio Menichelli, MD||Division of Cardiology "Fabrizio Spaziani" Hospital Frosinone, Italy|