The ATLANTA First in Man Study of the Catania Stent

CeloNova BioSciences

Status and phase: Completed; Phase 1

Conditions: Coronary Artery Disease

Treatments: Device: PCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799032

CL-PC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Stent

Other group

Description:

Catania Stent

Treatment:

Device: PCI