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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Ospedale Santa Maria Goretti.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Ospedale Santa Maria Goretti

ClinicalTrials.gov Identifier:

NCT01060306

First received: February 1, 2010

Last updated: NA

Last verified: January 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 1, 2010

Last Updated Date

February 1, 2010

Start Date ^ICMJE

January 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Bare metal stent 1 month
Patients implanted with the bare metal stent Gazelle evaluated for neointimal coverage one month after implantation
Biodegradable polymer stent 6 months
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
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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gregory A Sgueglia, MD		g.a.sgueglia@gmail.com
Contact: Daniel Todaro, MD		danieltodaro@libero.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01060306

Other Study ID Numbers ^ICMJE

SMG-005

Has Data Monitoring Committee

Responsible Party

UOC Emodinamica e Cardiologia Interventistica, Ospedale Santa Maria Goretti

Study Sponsor ^ICMJE

Ospedale Santa Maria Goretti

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Ospedale Santa Maria Goretti

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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