Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05209412
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2022-01-12
Brief Title:
Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions an Open-label Multicenter Randomized Non-inferiority Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
CAGE-FREEIII
Brief Summary:
Coronary restenosis has been one of the main reasons affecting the prognosis of patients with coronary artery disease CAD after percutaneous coronary intervention PCI With drug-eluting stents DES which elutes an antiproliferative drug to the vessel wall and reduces the restenosis rate however the incidence of restenosis is still about 10 The late stent thrombosis and restenosis with a hazard of nearly 2 per year after implantation remained a concern and motivated the development of drug-coated balloons DCB
DCB angioplasty has the following advantages compared with DES implantation Firstly the drug in DCB is uniformly distributed and released whereas the drug release of DES via stent platform is uneven -85 of the vascular wall is not covered by the stent strut Secondly there is no alloy in the vessel after DCB angioplasty while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia Finally there is no metal cage restraining vessel motion after DCB the physiological function of coronary arteries would be maintained
Studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease The application of DCB in large vessels with de novo lesions is still to be investigated The DEBUT study showed that in high bleeding risk patients aimed using only 1-month DAPT DCB was superior to BMS in terms of MACE MACE cardiovascular mortality nonfatal myocardial infarction or revascularization of ischemia-reperfusion target lesions at 9-month follow-up
However there is still a lack of evidence comparing the DCB versus DES in large vessels with de novo lesions The current study aims to investigate if in patients undergoing PCI for de novo stenoses in large vessels DCB is non-inferior to DES
DCB angioplasty has the following advantages compared with DES implantation Firstly the drug in DCB is uniformly distributed and released whereas the drug release of DES via stent platform is uneven -85 of the vascular wall is not covered by the stent strut Secondly there is no alloy in the vessel after DCB angioplasty while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia Finally there is no metal cage restraining vessel motion after DCB the physiological function of coronary arteries would be maintained
Studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease The application of DCB in large vessels with de novo lesions is still to be investigated The DEBUT study showed that in high bleeding risk patients aimed using only 1-month DAPT DCB was superior to BMS in terms of MACE MACE cardiovascular mortality nonfatal myocardial infarction or revascularization of ischemia-reperfusion target lesions at 9-month follow-up
However there is still a lack of evidence comparing the DCB versus DES in large vessels with de novo lesions The current study aims to investigate if in patients undergoing PCI for de novo stenoses in large vessels DCB is non-inferior to DES
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