Study of ABSORB Stent in Acute Myocardial Infarction

NCT ID: NCT02071342

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-09-30

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 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 .

Conditions

Acute Myocardial Infarction; Artery; Deformity, Coronary (Acquired)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

angioplasty

Intervention Type: PROCEDURE

patients with acute coronary syndrome and coronary angioplasty with bioresorbable vascular scaffold.

Interventions

angioplasty

patients with acute coronary syndrome and coronary angioplasty with bioresorbable vascular scaffold.

Intervention Type: PROCEDURE

Other Intervention Names

bioabsorbable everolimus-eluting coronary stent; everolimus-eluting bioresorbable vascular scaffold (BVS)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umberto I Hospital, Frosinone Italy

OTHER

Sponsor Role: lead

Responsible Party

Menichelli Maurizio

Director Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurizio Menichelli, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology "Fabrizio Spaziani" Hospital Frosinone, Italy

Locations

Division of interventional cardiology, Umberto I Hospital

Frosinone, Frosinone, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maurizio Menichelli, MD

Role: CONTACT

menichelli747@yahoo.com

+393382642317

Facility Contacts

Maurizio Menichelli, MD

Role: primary

menichelli747@yahoo.com

+39 3382642317

Other Identifiers

350/O/13

Identifier Type: -

Identifier Source: org_study_id