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
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Artery; Deformity, Coronary (Acquired)
Procedure: angioplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of ABSORB Stent in Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Umberto I Hospital, Frosinone Italy:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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


Estimated Enrollment: 300
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)
Groups/Cohorts Assigned Interventions
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)

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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with acute coronary syndrome who are undergoing coronary angioplasty.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071342

Contacts
Contact: Maurizio Menichelli, MD +393382642317 menichelli747@yahoo.com

Locations
Italy
Division of interventional cardiology, Umberto I Hospital Recruiting
Frosinone, Italy, 030100
Contact: Maurizio Menichelli, MD    +39 3382642317    menichelli747@yahoo.com   
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         
Sponsors and Collaborators
Umberto I Hospital, Frosinone Italy
Investigators
Principal Investigator: Maurizio Menichelli, MD Division of Cardiology "Fabrizio Spaziani" Hospital Frosinone, Italy
  More Information

No publications provided

Responsible Party: Menichelli Maurizio, Director Division of Cardiology, Umberto I Hospital, Frosinone Italy
ClinicalTrials.gov Identifier: NCT02071342     History of Changes
Other Study ID Numbers: 350/O/13
Study First Received: January 2, 2014
Last Updated: February 23, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Umberto I Hospital, Frosinone Italy:
acute myocardial infarction
bioresorbable vascular scaffold
percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014