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

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ClinicalTrials.gov Identifier: NCT01060306
Recruitment Status : Unknown
Verified January 2010 by Ospedale Santa Maria Goretti.
Recruitment status was:  Recruiting
First Posted : February 2, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:

February 1, 2010
February 2, 2010
February 2, 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 ]
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 ]
  • 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 ]
  • 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 ]
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.
 
Unknown status
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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01060306
SMG-005
No
Not Provided
Not Provided
UOC Emodinamica e Cardiologia Interventistica, Ospedale Santa Maria Goretti
Ospedale Santa Maria Goretti
Not Provided
Not Provided
Ospedale Santa Maria Goretti
January 2010