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
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Optical cohereNce Tomography Evaluation of neoINtimal Coverage of a biodegrAdable Polymer-based Drug-eluting Stent

Resource links provided by NLM:


Further study details as provided by Ospedale Santa Maria Goretti:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: January 2011
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060306

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

Locations
Italy
UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti Recruiting
Latina, Italy, 04100
Contact: Gregory A Sgueglia, MD       g.a.sgueglia@gmail.com   
Contact: Daniel Todaro, MD       danieltodaro@libero.it   
Principal Investigator: Gregory A Sgueglia, MD         
Sub-Investigator: Daniel Todaro, MD         
Sponsors and Collaborators
Ospedale Santa Maria Goretti
  More Information

No publications provided

Responsible Party: UOC Emodinamica e Cardiologia Interventistica, Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier: NCT01060306     History of Changes
Other Study ID Numbers: SMG-005
Study First Received: February 1, 2010
Last Updated: February 1, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014