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

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Status: Withdrawn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)