NCT01060306

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 1, 2010

Last Update Submit

February 21, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

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 Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • age \>50 years
  • de novo lesion
  • lesion length \<24 mm
  • reference vessel diameter 3 mm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

January 1, 2011

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations

IT(1)