NCT02086006

Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial

A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolveTM MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions \< 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus. * Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months. * Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months. * Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Timeline

• Start date: 2011-02-01
• Primary completion: 2016-10-01
• Completion: 2017-04-01
• First posted: 2014-03-13
• Last updated: 2023-09-07

Locations

3 sites across 2 countries: Belgium, New Zealand