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

February 23, 2014 updated by: Menichelli Maurizio, Umberto I Hospital, Frosinone Italy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Frosinone, Italy, 030100
        • Recruiting
        • Division of interventional cardiology, Umberto I Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with acute coronary syndrome who are undergoing coronary angioplasty.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (Death, MI, TLR and TVR)
Time Frame: One year after index procedure
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
One year after index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute stent Recoil
Time Frame: Within ten minutes after scaffold implantation
Evaluation of acute recoil after implantation of bioabsorbable stent (BVS).
Within ten minutes after scaffold implantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
conformability
Time Frame: immediately after implantation of the device
Evaluation of the conformability of the stent and the vessel curvature and angle before and after implantation of the device
immediately after implantation of the device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umberto I Hospital, Frosinone Italy

Investigators

  • Principal Investigator: Maurizio Menichelli, MD, Division of Cardiology "Fabrizio Spaziani" Hospital Frosinone, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

February 23, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 23, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 350/O/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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