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Trial record 1 of 2 for:    22529227 [PUBMED-IDS]
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Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02151929
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Procedural and Clinical success [ Time Frame: Patients will be followed for the duration of hospital stay (4-8 days) ]

    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 :
  1. The MACE [ Time Frame: six months ]
    cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization


Other Outcome Measures:
  1. stent thrombosis [ Time Frame: six months ]
    cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital:
myocardial infarction
primary PCI
stent

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