Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01781546
Status:
TERMINATED
Last Update Posted:
2018-01-30
First Post:
2013-01-29
Brief Title:
Drug-Eluting Balloon in Stable and Unstable Angina
Sponsor:
North Karelia Central Hospital
Organization:
North Karelia Central Hospital
Study Overview
Official Title:
Drug-Eluting Balloon in Stable and Unstable Angina a Randomized Controlled Non-inferiority Trial
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
suspeded due to slow recruitment terminated due to interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEBUT
Brief Summary:
The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS UAP or NSTEMI in patients at high risk of bleeding
Detailed Description:
Stenting has reduced the need of revascularization procedures in stable CAD and ACS as compared to POBA The use of stents is favored in stable CAD and in ACS according the the present ESC guidelines However especially in patients on warfarin or in patients at a high bleeding risk stenting and the use of DES in particular is not recommended because of the longer DAPT required In these patients BMS may be used to shorten the duration of DAPT However there are problems associated with the treatment using BMS First of all a considerable high rate of restenosis is associated with stenting with BMS Furthermore stenting may be complicated by the no-reflow phenomenon a coronary dissection or the closure of side branch during the treatment of bifurcation lesions Implantation of a stent also exposes the patient to stent thrombosis In contrast these problems may be avoided by the use of DEB with the provisional BMS strategy
The use of DEB has already been established in the treatment of ISR Despite the lack of data of RCTs DEB is already widely used in a variety of clinical situations in which stenting is not desirable These situations include for example anticoagulation treatment a high bleeding risk poor compliance regarding medication small vessels bifurcation lesions long andor calcified lesions in case of a marked variation in the vessel reference caliber in long lesions and in patients with ACS The all-comer registry data is promising but only hypothesis generating Thus it would be very important and ethical to test the efficacy of DEB in a wider patient population in a randomized controlled study
Our hypothesis is that DEB is non-inferior to BMS in the treatment of stable CAD or in ACS UAP or NSTEMI in patients on anticoagulation medication or otherwise having a high bleeding risk Our study sheds light on the use of DEB in PCI of this challenging patient population In most previous studies BMS has been routinely added to the DEB treatment This strategy seems not to yield any benefit but in contrast causes an increased risk of restenosis as compared to the DEB only strategy with provisional stenting Finally the current data on the use of DEB in patients with ACS is scarce and our study gives significant information also on this important issue
The use of DEB has already been established in the treatment of ISR Despite the lack of data of RCTs DEB is already widely used in a variety of clinical situations in which stenting is not desirable These situations include for example anticoagulation treatment a high bleeding risk poor compliance regarding medication small vessels bifurcation lesions long andor calcified lesions in case of a marked variation in the vessel reference caliber in long lesions and in patients with ACS The all-comer registry data is promising but only hypothesis generating Thus it would be very important and ethical to test the efficacy of DEB in a wider patient population in a randomized controlled study
Our hypothesis is that DEB is non-inferior to BMS in the treatment of stable CAD or in ACS UAP or NSTEMI in patients on anticoagulation medication or otherwise having a high bleeding risk Our study sheds light on the use of DEB in PCI of this challenging patient population In most previous studies BMS has been routinely added to the DEB treatment This strategy seems not to yield any benefit but in contrast causes an increased risk of restenosis as compared to the DEB only strategy with provisional stenting Finally the current data on the use of DEB in patients with ACS is scarce and our study gives significant information also on this important issue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None