NCT00799032

Brief Summary

To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for the treatment of up to two de novo lesions in native coronary arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 coronary-artery-disease

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
4 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
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

November 25, 2008

Last Update Submit

June 6, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary Stent

Outcome Measures

Primary Outcomes (1)

  • Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI

    In Hospital

Secondary Outcomes (1)

  • Any death, cardiac death, stent related fatal / non fatal Myocardial Infarction, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Binary Restenosis

    1 and 6 months

Study Arms (1)

Stent

OTHER

Catania Stent

Device: PCI

Interventions

PCIDEVICE

coronary stent implantation

Also known as: Catania Stent
Stent

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lesion length ≤ 20 mm
  • Vessel size ≥ 2.5 ≤ 3.5 mm

You may not qualify if:

  • Life expectancy \< 1 year
  • Left ventricular ejection fraction (LVEF) \<30%
  • Anti-thrombotic drug intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferrarotto Hospital

Catania, Sicily, 95124, Italy

Location

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
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 27, 2008

Study Start

May 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2008

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

IT(1)