Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT02453035
Status:
TERMINATED
Last Update Posted:
2021-04-26
First Post:
2015-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DESolve® X-Pand Global Post Market Registry
Sponsor:
Elixir Medical Corporation
Organization:
Study Overview
Official Title:
X-Pand is Intended to Use the DESolve Scaffold System in Treatment of CAD Patients, by Including "Real World" Use of the DESolve Scaffold Over a Broad Spectrum of Geographies, A Wide Variety of Practicing Clinicians & A Minimum Degree Of Selection Criteria
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment due to change in worldwide scaffold usage
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
X-Pand
Brief Summary:
The X-Pand Registry is intended to facilitate analysis of acute \& long-term safety as well as treatment outcomes with DESolve in patients with CAD.
Detailed Description:
The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold.
The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines \& internal hospital guidelines.
The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines \& internal hospital guidelines.
Study Oversight
Has Oversight DMC:
False
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?: