An observational study in Coronary Artery Disease, sponsored by Ospedale Santa Maria Goretti. Withdrawn at 1 site in Italy. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Ospedale Santa Maria Goretti · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
Browse Coronary Artery Disease studies →Ospedale Santa Maria Goretti is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients implanted with the bare metal stent Gazelle evaluated for neointimal coverage one month after implantation
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)
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)
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
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
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Ospedale Santa Maria Goretti