Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03773081
Status:
TERMINATED
Last Update Posted:
2019-09-17
First Post:
2018-12-09
Brief Title:
SOLVE-ACS Bioresorbable Magnesium-Stents Magmaris in ACS Lesions
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
SOLVE-ACS Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome ACS
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLVE-ACS
Brief Summary:
The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium Stent in STE-ACS and NSTE-ACS patients
Detailed Description:
The Magmaris Magnesium-Stent is indicated for improving luminal diameter and stabilize culprit lesions in patients with coronary artery disease CAD including ST-segment elevation STE- as well as Non-ST-segment elevation NSTE- acute coronary syndrome ACS Patients scheduled for this registry must have one angiographic clear detectable ACS-causing culprit lesion with a reference diameter and a lesion length which closely match the nominal Magmaris reference diameter and length
Primary endpoint will be the procedural angiographical success at the end of PCI defined as successful Magmaris implantation at the culprit lesion site with less than 30 final stenosis by visual estimation and distal TIMI 3 flow Secondary endpoints will include clinical and angiographic parameters as well as parameters gained through OCT-imaging
Primary endpoint will be the procedural angiographical success at the end of PCI defined as successful Magmaris implantation at the culprit lesion site with less than 30 final stenosis by visual estimation and distal TIMI 3 flow Secondary endpoints will include clinical and angiographic parameters as well as parameters gained through OCT-imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None