Study of ABSORB Stent in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— ABSORB-ACS  

Official title:

Study of ABSORB Stent in Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02071342
• Other study ID #: 350/O/13
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2014
• Last updated: February 23, 2014
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2014
• Source: Umberto I Hospital, Frosinone Italy
• Contact: Maurizio Menichelli, MD
• Phone: +393382642317
• Email: menichelli747[@]yahoo.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• angioplasty
patients with acute coronary syndrome and coronary angioplasty with bioresorbable vascular scaffold.

Locations

Country	Name	City	State
Italy	Division of interventional cardiology, Umberto I Hospital	Frosinone

Sponsors (1)

Lead Sponsor	Collaborator
Umberto I Hospital, Frosinone Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	conformability	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	Yes
Primary	MACE (Death, MI, TLR and TVR)	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	Yes
Secondary	Acute stent Recoil	Evaluation of acute recoil after implantation of bioabsorbable stent (BVS).	Within ten minutes after scaffold implantation	Yes