Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06166459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2023-12-03
Brief Title:
Yao Strategy for the Treatment of de Novo Medina 010 or 001 Bifurcation Lesion
Sponsor:
Xuzhou Third Peoples Hospital
Organization:
Xuzhou Third Peoples Hospital
Study Overview
Official Title:
Drug-coated Balloon Combined With Provisional Drug-eluting Stent Implantation Yao Strategy for the Treatment of de Novo Medina 010 or 001 Bifurcation Lesion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 010 or 001 bifurcation lesion In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions the following 2 treatment strategies are available 1 DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required DCBpDES strategy 2 DES implantation 1-2 mm distally to the lesion ostium followed by DCB DESDCB strategy The primary endpoint was late lumen loss and major adverse cardiovascular events
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