NCT03634020

DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System

Evaluation of a Thin Strut Metallic Coronary Device: the Elixir DynamXTM Sirolimus Eluting Coronary Bioadaptor System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

Detailed description

The DynamX Sirolimus Study is a prospective, consecutive enrollment, single-arm study designed to enroll up to 30 patients requiring treatment of up to two de novo lesions ≤ 24 mm in length in vessels ≥ 2.5 mm and ≤ 3.5 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 DynamX SECBS. Alternatively, one target lesion may be treated with the DynamX SECBS after successful, uncomplicated treatment of a non-target lesion, located in a separate epicardial vessel, with any commercially-available DES. Acceptable example: non-target RCA lesion and LAD target lesion. Not acceptable example: LAD non-target lesion and 1st diagonal target lesion. 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 efficacy endpoint is late lumen loss at 6 months, assessed by angiography Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and 12 months Using visual assessment, the target lesion must measure ≥ 2.5 mm and ≤ 3.5 mm in diameter and ≤ 24 mm in length able to be covered by a single DynamX Sirolimus Bioadaptor including 2 mm of healthy vessel on either side of the planned treatment area. The patient will be eligible for stent (also called bioadaptor) 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 DynamX SECBS

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DynamX Sirolimus-eluting Coronary Bioadaptor System	de novo native coronary artery lesions

Timeline

• Start date: 2018-12-10
• Primary completion: 2021-03-08
• Completion: 2021-03-08
• First posted: 2018-08-16
• Last updated: 2021-04-26

Locations

7 sites across 1 country: New Zealand

Regulatory

• FDA-regulated device study