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

Withdrawn

• Conditions: Coronary Artery Disease

• Registration Number: NCT01060306
• Lead Sponsor: Ospedale Santa Maria Goretti

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2010-08
• Study Completion: 2011-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti; 🇮🇹 Latina, Italy