Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-01-13 @ 3:31 PM
Study NCT ID:
NCT02086006
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2014-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial
Sponsor:
Elixir Medical Corporation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: