An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction with Bare Metal Stenting in Patients with De Novo Coronary Lesions

Phase 2

Completed

• Conditions: coronary artery disease; angina pectoris; 10011082

• Registration Number: NL-OMON33221
• Lead Sponsor: utonix

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Documented stable angina pectoris CCSC 1-4, unstable angina pectoris with documented ischemia (Braunwald 1-II) or documented silent ischemia
Target lesion is a de novo lesion in a native coronary artery vessel
Initial stenosis is >50% and <100% by visual estimate or QCA
Target lesion is <18 mm in lenght and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS

Exclusion Criteria

History of Stroke within past 6 months
History of MI or thrombolysis within 72 hours of randomization
Prior vascular brachytherapy
Angiographic evidece of thrombus or dissection within the target vessel

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean percent stent volume obstruction at 6 months.</p><br>