Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04814212
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2021-03-22
Brief Title:
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Sponsor:
North Karelia Central Hospital
Organization:
North Karelia Central Hospital
Study Overview
Official Title:
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Status:
RECRUITING
Status Verified Date:
2023-11
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:
DEBATE
Brief Summary:
The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk If non-inferiority is shown the superiority of the DCB strategy over DES strategy will be tested
Detailed Description:
Implantation of a drug-eluting stent DES has become a standard of percutaneous coronary intervention PCI during the last two decades However there are still significant drawbacks in using DES as a permanent coronary implant Most importantly bleeding remains a significant complication of PCI especially in elderly patients The number of PCI patients having OACs is already significant and will grow in the future as the volume of PCIs in octogenarians increases and so does the incidence of atrial fibrillation by age After stenting at least one month lasting dual antiplatlet treatment DAPT is mandatory and it cannot be safely terminated in case of a bleed The optimal duration of DAPT on patients at bleeding risk is not known
Balloon coated with paclitaxel and iopromide drug-coated balloon DCB was originally developed for the treatment of in-stent restenosis but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials So far the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing
The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS UAP or NSTEMI in patients on anticoagulation medication or otherwise on high bleeding risk If non-inferiority is shown the superiority of the DCB strategy over DES strategy will be tested
Balloon coated with paclitaxel and iopromide drug-coated balloon DCB was originally developed for the treatment of in-stent restenosis but later its potential for the treatment of de-novo coronary artery leasons has become clear in large registry trials So far the randomized controlled studies have shown the non-inferiority of PCI using DCB in comparison to DES in de novo leasons in small vessels Also the non-inferiority of PCI using DCB in comparison to BMS was shown in the DEBUT trial in large vessels on patients at high bleeding risk These results need to be confirmed in comparison of DCB to DES as the use of BMS is diminishing
The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration in the treatment of stable CAD or in ACS UAP or NSTEMI in patients on anticoagulation medication or otherwise on high bleeding risk If non-inferiority is shown the superiority of the DCB strategy over DES strategy will be tested
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