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Trial record 2 of 2 for:    absorb everolimus | Ischemic | Italy

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

Tracking Information
First Submitted Date  ICMJE May 22, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
The MACE [ Time Frame: six months ]
cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2014)
stent thrombosis [ Time Frame: six months ]
cumulative incidence of definite or probable stent thrombosis defined according to the Academic Research Consortium definition
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction
Official Title  ICMJE Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent
Brief Summary Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ST Elevation Acute Myocardial Infarction
Intervention  ICMJE
  • Device: Bioresorbable vascular scaffold
    stenting of an acute thrombotic lesion in patient within STEMI
    Other Name: BVS, ABSORB (Abbot Vascular)
  • Device: Everolimus eluting stent
    stenting of an acute thrombotic lesion in patient within STEMI
    Other Name: Xience Prime (Abbott Vascular)
Study Arms  ICMJE
  • Experimental: Bioresorbable Vascular Scaffold
    Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI
    Intervention: Device: Bioresorbable vascular scaffold
  • Active Comparator: Everolimus Eluting stent
    Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI
    Intervention: Device: Everolimus eluting stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2014)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02151929
Other Study ID Numbers  ICMJE AOM_BVS1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital
Study Sponsor  ICMJE San Giuseppe Moscati Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emilio Di Lorenzo, MD PhD Division of Cardiology AO Moscati Avellino ITALY
PRS Account San Giuseppe Moscati Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP