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

O

Ospedale Santa Maria Goretti

Status

Withdrawn

Conditions

Coronary Artery Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01060306
SMG-005

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Bare metal stent 1 month
Description:
Patients implanted with the bare metal stent Gazelle evaluated for neointimal coverage one month after implantation
Biodegradable polymer stent 6 months
Description:
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
Description:
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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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