Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent (PONTINA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Ospedale Santa Maria Goretti.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier:
NCT01060306
First received: February 1, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

February 1, 2010
February 1, 2010
January 2010
Not Provided
Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Comparison of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation and of its bare metal stent counterpart (Gazelle) one month after implantation [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Comparison of the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months) and at one month after this time-point (7 months) [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent
Prospective Optical cohereNce Tomography Evaluation of neoINtimal Coverage of a biodegrAdable Polymer-based Drug-eluting Stent

PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months), at one month after this time-point (7 months) and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after implantation.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with stable or unstable coronary artery disease undergoing percutaneous coronary intervention on the left anterior descending artery with a Biomatrix stent placement or on the left circumflex artery with a Gazelle stent placement

Coronary Artery Disease
Not Provided
  • Bare metal stent 1 month
    Patients implanted with the bare metal stent Gazelle evaluated for neointimal coverage one month after implantation
  • Biodegradable polymer stent 6 months
    Patients implanted with the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) evaluated for neointimal coverage after full drug elution and polymer biodegradation (6 months)
  • Biodegradable polymer stent 7 months
    Patients implanted with the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) evaluated for neointimal coverage one month after full drug elution and polymer biodegradation (7 months)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2011
Not Provided

Inclusion Criteria:

  • age >50 years
  • de novo lesion
  • lesion length <24 mm
  • reference vessel diameter 3 mm

Exclusion Criteria:

  • low compliance to dual antiplatelet therapy
  • life expectancy <1 year
  • allergy to any drug or substance use prior, during or after percutaneous coronary intervention
  • chronic renal insufficiency
  • low left ventricle ejection fraction (<35%)
  • recent acute myocardial infarction
  • previous coronary intervention
  • off-label indication to stenting
  • participation in another investigation
  • refusal to participate to the study
Both
50 Years to 85 Years
No
Contact: Gregory A Sgueglia, MD g.a.sgueglia@gmail.com
Contact: Daniel Todaro, MD danieltodaro@libero.it
Italy
 
NCT01060306
SMG-005
No
UOC Emodinamica e Cardiologia Interventistica, Ospedale Santa Maria Goretti
Ospedale Santa Maria Goretti
Not Provided
Not Provided
Ospedale Santa Maria Goretti
January 2010

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