The ATLANTA First in Man Study of the Catania Stent

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799032

Acronym

ATLANTA

Enrollment

Registered

2008-11-27

Start date

2007-05-31

Completion date

2008-08-31

Last updated

2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Stent

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.

Interventions

DEVICEPCI

coronary stent implantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Procedural success, Target Lesion Revascularization, Target Vessel Revascularization, Stent Thrombosis, Cardiac death, fatal/non fatal MI	In Hospital

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026