Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961787
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2022-12-06
Brief Title:
A Trial of DCB vs DES in the Treatment of de Novo Large Diameter Coronary Atherosclerotic StenosisLARGE ONE
Sponsor:
Shanghai MicroPort Medical Group Co Ltd
Organization:
Shanghai MicroPort Medical Group Co Ltd
Study Overview
Official Title:
LARGE-ONE A Prospective Multicenter Randomized Controlled Trial of the Use of Drug-coating BalloonsDCB or Drug-eluting StentsDES in the Treatment of Large Diameter Coronary Atherosclerotic Lesions
Status:
RECRUITING
Status Verified Date:
2023-07
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:
LARGE-ONE
Brief Summary:
For the treatment of primary large-diameter coronary atherosclerosis through percutaneous coronary intervention PCI the use of a drug balloon DCB is not inferior to the placement of a drug-eluting stent Firehawk family
Large-diameter vessels were defined as vessels with a diameter of 300 mm and 40mm
Large-diameter vessels were defined as vessels with a diameter of 300 mm and 40mm
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