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NCT01060306 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— PONTINA  

Official title:
Prospective Optical cohereNce Tomography Evaluation of neoINtimal Coverage of a biodegrAdable Polymer-based Drug-eluting Stent

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01060306
Other study ID # SMG-005
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 2010
Est. completion date January 2011

Study information
Verified date February 2020
Source Ospedale Santa Maria Goretti
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2011
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti Latina

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Santa Maria Goretti

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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