Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:
NCT02151929
First received: May 22, 2014
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).


Condition Intervention Phase
ST Elevation Acute Myocardial Infarction
Device: Bioresorbable vascular scaffold
Device: Everolimus eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent

Resource links provided by NLM:


Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:
  • Procedural and Clinical success [ Time Frame: Patients will be followed for the duration of hospital stay (4-8 days) ] [ Designated as safety issue: Yes ]

    Procedural success: The deployment of BVS at the intended target lesion with a final residual stenosis ≤20% and a TIMI 2-3 coronary flow by visual estimation without major periprocedural complication (death, emergent CABG, coronary perforation, flow limiting coronary dissection).

    Clinical success: any major in-hospital events (deaths, reinfarction, urgent revascularization, stroke, major bleedings)



Secondary Outcome Measures:
  • The MACE [ Time Frame: six months ] [ Designated as safety issue: No ]
    cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization


Other Outcome Measures:
  • stent thrombosis [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition


Enrollment: 100
Study Start Date: May 2013
Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioresorbable Vascular Scaffold
Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI
Device: Bioresorbable vascular scaffold
stenting of an acute thrombotic lesion in patient within STEMI
Other Name: BVS, ABSORB (Abbot Vascular)
Active Comparator: Everolimus Eluting stent
Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI
Device: Everolimus eluting stent
stenting of an acute thrombotic lesion in patient within STEMI
Other Name: Xience Prime (Abbott Vascular)

Detailed Description:

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. chest pain for more than 30 minutes;
  2. ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

Exclusion Criteria:

  1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
  2. Contraindication to dual antiplatelet therapy for 12 months;
  3. Known allergy to everolimus;
  4. A history of stroke within 30 days or any history of hemorrhagic stroke;
  5. History, symptoms, or findings suggestive of aortic dissection;
  6. High-likelihood of death within BVS resorbtion time;
  7. Cardiogenic shock;
  8. Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes);
  9. Pregnancy;
  10. Participation in other trials
  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: NCT02151929

Locations
Italy
Division of Cardiology Ao Moscati
Avellino, Italy, 83100
Sponsors and Collaborators
San Giuseppe Moscati Hospital
Investigators
Principal Investigator: Emilio Di Lorenzo, MD PhD Division of Cardiology AO Moscati Avellino ITALY
  More Information

Publications:

Responsible Party: Emilio Di Lorenzo MD PhD, Dott. Emilio Di Lorenzo, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier: NCT02151929     History of Changes
Other Study ID Numbers: AOM_BVS1
Study First Received: May 22, 2014
Last Updated: May 30, 2014
Health Authority: Italy: National Institute of Health

Keywords provided by San Giuseppe Moscati Hospital:
myocardial infarction
primary PCI
stent

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 29, 2014