Status:

COMPLETED

The ATLANTA First in Man Study of the Catania Stent

Lead Sponsor:

CeloNova BioSciences, Inc.

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

30-70 years

Phase:

PHASE1

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.

Detailed Description

This is a prospective, non-randomized, first-in-man single center study. The study requires a 55 patients with documented myocardial ischemia undergoing PCI.

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

May 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00799032

Start Date

May 1 2007

End Date

August 1 2008

Last Update

June 7 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ferrarotto Hospital

Catania, Sicily, Italy, 95124