Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03955731
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2019-02-11
Brief Title:
OCT Guided Magmaris RMS in STEMI
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Optical Coherence Guided Treatment of ST-segment Elevation Myocardial Infarction With the Drug-eluting Resorbable Magnesium Scaffold the BEST- MAG Multicentre Study BElgian ST-segment Elevation Myocardial Infarction Treatment With Resorbable MAGnesium Scaffold
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
Recruiting
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:
BESTMAG
Brief Summary:
Percutaneous treatment of coronary artery disease depends on the implantation of stents within diseased coronary segments Compared with conventional bare-metal and drug- eluting stents which remain permanently within the coronary anatomy bioresorbable scaffolds BRS offer several potential advantages due to its resorbable properties The resorbable magnesium scaffold Magmaris has demonstrated favourable outcomes in patients with stable coronary artery disease In particular in comparison to polymeric bioresorbable scaffolds no cases of stent thrombosis have been reported in over two years of follow-up suggesting that magnesium-based resorbable scaffolds have low thrombogenicity and might be particularly beneficial for patients presenting with ST- segment myocardial infarction A recent pilot study in eighteen patients supports this concept which has led to the development of the proposed prospective multicentre study including intra-coronary imaging with long-term clinical follow-up
Detailed Description:
None
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