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Completed

NCT Number: NCT00799032

The ATLANTA First in Man Study of the Catania Stent

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ferrarotto Hospital

Catania, Sicily, 95124, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PCI

Device

coronary stent implantation

Other names: Catania Stent

Primary outcomes

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

    Time frame: 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

    Time frame: 1 and 6 months

Sponsors and collaborators

Lead sponsor

CeloNova BioSciences, Inc.

Industry

Registry information

Official study title

Assessment of The Latest Non-Thrombogenic Angioplasty Stent (ATLANTA): Prospective, First in Man, Non-Randomized, Single Center for Patients With Documented Myocardial Ischemia Undergoing PCI

Acronym: ATLANTA

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Nov 27, 2008
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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