NCT00799344

Brief Summary

To address early vessel healing and thrombus formation after deployment of three distinct groups of stents

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

November 25, 2008

Last Update Submit

January 15, 2014

Conditions

Coronary Artery Disease

Keywords

Coronary Stent

Outcome Measures

Primary Outcomes (1)

  • percentage of "healed stent struts" at 28-32 days

    30 days

Secondary Outcomes (1)

  • Measurement of neointimal growth on stent struts

    30 days

Study Arms (1)

Stent

Catania Stent

Device: Catania Stent

Interventions

Catania StentDEVICE

coronary stent implantation

Stent

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that have two significant short lesions

You may qualify if:

  • Lesion length ≤ 20 mm
  • Two significant short lesions

You may not qualify if:

  • Life expectancy \< 1 year
  • Left ventricular ejection fraction (LVEF) \<30%
  • Chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferrarotto Hospital

Catania, Sicily, 95124, Italy

Location

Related Publications (1)

  • La Manna A, Prati F, Capodanno D, Di Salvo M, Sanfilippo A, Barrano G, Monaco S, Tamburino C. Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient. J Cardiovasc Med (Hagerstown). 2011 May;12(5):328-33. doi: 10.2459/JCM.0b013e3283406428.

    PMID: 20962664DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Corrado Tamburino, MD

    Ferrarotto Hospital, University of Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 27, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

IT(1)