NCT04192747

The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions

Detailed description

The Bioadaptor RCT Study is a prospective, 1:1 randomized study of parallel designed, that will enroll up to 444 patients requiring treatment of up to two de novo coronary lesions of ≤ 34 mm in length in vessels of ≥ 2.25 mm and ≤ 4.0 mm in diameter. One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or LAD), and meeting the inclusion/exclusion criteria may be treated with the ELX1805J (DynamX Bioadaptor) or Resolute Onyx stent The primary safety endpoint is Target Lesion Failure (TLF) at 12 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and 12 months and 2-5 years. Using visual assessment, the target lesion must measure ≥ 2.25 mm and ≤ 4.0 mm in diameter and ≤ 34 mm in length able to be covered by a single ELX1805J or Resolute Onyx stent including 2 mm of healthy vessel on either side of the planned treatment area. The patient will be eligible for device implantation only after satisfactory lesion pre-dilatation defined as: ≥ TIMI 2 flow, and no dissection greater than Grade B (NHLBI) able to be covered with a single device

Conditions

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Intervention	Percutaneous coronary intervention of de novo native coronary artery lesions

Timeline

• Start date: 2020-12-16
• Primary completion: 2023-02-28
• Completion: 2027-02-28
• First posted: 2019-12-10
• Last updated: 2025-03-24
• Results posted: 2024-10-22

Locations

36 sites across 4 countries: Belgium, Germany, Japan, New Zealand

Regulatory

• FDA-regulated device study