Study of ABSORB Stent in Acute Myocardial Infarction

NCT02071342 | Unknown

• 1 other identifier: 350/O/13
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

acute myocardial infarction; bioresorbable vascular scaffold; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Acute stent Recoil

  Within ten minutes after scaffold implantation

Other Outcomes (1)

• conformability

  immediately after implantation of the device

Study Arms (1)

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

Interventions

angioplasty PROCEDURE

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

Also known as: bioabsorbable everolimus-eluting coronary stent, everolimus-eluting bioresorbable vascular scaffold (BVS)

acute coronary syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute coronary syndrome who are undergoing coronary angioplasty.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umberto I Hospital, Frosinone Italy: lead

Study Sites (1)

Division of interventional cardiology, Umberto I Hospital

Frosinone, Frosinone, 030100, Italy

RECRUITING

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Maurizio Menichelli, MD

  Division of Cardiology "Fabrizio Spaziani" Hospital Frosinone, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Menichelli, MD

CONTACT

+393382642317; menichelli747@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Division of Cardiology

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: February 25, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

IT (1)