A Clinical Evaluation of the XIENCE TM V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Coronary Artery Lesions

Completed

• Conditions: coronary artery lesions; 10003216

• Registration Number: NL-OMON29915
• Lead Sponsor: Abbott

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 225

Inclusion Criteria

Maximum of one, de novo, target lesion per native major epicardial vessel or side branch (no prior stent implant, no prior brachytherapy
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
Target lesion <28 mm in length by visual estimation
Target lesion must be in a major artery or branch with a visually estimated stenosis of >50% and <100% and a TIMI flow>1
Spirit V Registry: According tot he instructions for Use (IFU)

Exclusion Criteria

Patient has had a known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
Patient has current unstable arrhythmias
Patient has a known left ventricular ejection fraction <30%
Spirit V Registry: According to the instructions for Use (IFU)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the SPIRIT V Diabetic Study is in-stent Late Loss (LL)<br /><br>at 270 days.<br /><br>The primary endpoint of the SPIRIT V Registry is Adjudicated Composite rate of<br /><br>All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)<br /><br>at 30 days.</p><br>