NCT03429894

Evaluation of a Thin Strut Metallic Stent: the Elixir DynamX Clinical Study

Evaluation of a Thin Strut Metallic Stent: the Elixir DynamXTM Novolimus Eluting Coronary Bioadaptor System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years. All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.

Detailed description

The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years. All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months. At select centers, a subset of approximately 20 patients will undergo FFR pressure wire measurement at baseline and at follow-up (or at a minimum follow-up) in conjunction with the IVUS imaging, and will also undergo OCT imaging at 9 or 12 months. The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization. The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is the change in mean in-device area and mean lumen area at 9 or 12 months compared to post-procedure as measured by IVUS. Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is late lumen loss as measured by QCA and IVUS at 9 or 12 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Intervention	Drug eluting stent implant

Timeline

• Start date: 2017-11-16
• Primary completion: 2019-09-17
• Completion: 2021-12-31
• First posted: 2018-02-12
• Last updated: 2022-07-20

Locations

2 sites across 2 countries: Belgium, Italy