ION US Post-Approval Study

Boston Scientific

Status: Completed

Conditions: Coronary Artery Disease; Atherosclerosis

Treatments: Device: ION™ Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT01422889

S2065

Details and patient eligibility

About

The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Full description

The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.

Enrollment: 1,120 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Consented subjects receiving one or more ION(TM)Coronary Stents

Exclusion criteria

Subjects not clinically indicated to receive an ION (TM)Coronary Stent

Trial design

1,120 participants in 1 patient group

ION Registry

Description:

The ION Registry population was designed to collect real world safety and clinical outcomes data. There were 1120 subjects were enrolled, however 9 subjects did not receive a study stent therefore 1111 subjects were eligible for follow up.

Treatment:

Device: ION™ Coronary Stent System