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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01060306

Acronym

PONTINA

Enrollment

Registered

2010-02-02

Start date

2010-01-31

Completion date

2011-01-31

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation	6 months

Secondary

Measure	Time frame
Assessment of neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) one month after full drug elution and polymer biodegradation	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	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)	7 months

Countries

Italy

Outcome results