Study of ABSORB Stent in Acute Myocardial Infarction (ABSORB-ACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Umberto I Hospital, Frosinone Italy
Sponsor:
Information provided by (Responsible Party):
Menichelli Maurizio, Umberto I Hospital, Frosinone Italy
ClinicalTrials.gov Identifier:
NCT02071342
First received: January 2, 2014
Last updated: February 23, 2014
Last verified: February 2014

January 2, 2014
February 23, 2014
September 2013
September 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02071342 on ClinicalTrials.gov Archive Site
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).
Same as current
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
Same as current
 
Study of ABSORB Stent in Acute Myocardial Infarction
Study of ABSORB Stent in Acute Coronary Syndrome

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.

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 .

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients with acute coronary syndrome who are undergoing coronary angioplasty.

  • Acute Myocardial Infarction
  • Artery; Deformity, Coronary (Acquired)
Procedure: angioplasty
patients with acute coronary syndrome and coronary angioplasty with bioresorbable vascular scaffold.
Other Names:
  • bioabsorbable everolimus-eluting coronary stent
  • everolimus-eluting bioresorbable vascular scaffold (BVS)
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
Intervention: Procedure: angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
September 2015
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients older than 18 years with acute coronary syndrome (STEMI and NSTEMI) will be enrolled

Exclusion Criteria:

  • patients with these characteristics will be excluded: cardiogenic shock (defined as systolic blood pressure less than 80 mmHg for more than 30 minutes or the need for compressors or intravenous-intraaortic balloon counterpulsation), history of bleeding diathesis, history of leukopenia , thrombocytopenia, or severe hepatic or renal dysfunction, a non-cardiac disease associated with a life expectancy of less than one year, participating in another study, or not able to give informed consent due to a prolonged resuscitation cardiopulmonary.
Both
18 Years and older
No
Contact: Maurizio Menichelli, MD +393382642317 menichelli747@yahoo.com
Italy
 
NCT02071342
350/O/13
No
Menichelli Maurizio, Umberto I Hospital, Frosinone Italy
Umberto I Hospital, Frosinone Italy
Not Provided
Principal Investigator: Maurizio Menichelli, MD Division of Cardiology "Fabrizio Spaziani" Hospital Frosinone, Italy
Umberto I Hospital, Frosinone Italy
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP