Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409981
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-12-11
Brief Title:
Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons PACCOCATH - ISR II
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons PACCOCATH - ISR II
Status:
COMPLETED
Status Verified Date:
2006-12
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:
The PACCOCATH ISR II study is a randomized double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis
Detailed Description:
Background Drug-eluting stents have shown promising anti-restenotic effects in clinical trials It may be preferable however to avoid the stent-in-stent approach in treating in-stent restenosis ISR In prior animal trials we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters DEB The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR
Methods and results The PACCOCATH ISR study is a randomized double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR Patients are randomized to rePTCA of ISR either using the coated PTCA balloon 3 µg paclitaxelmm² balloon surface or a non-coated balloon of the same type n56 patients Balloon inflation time is 60 seconds in both cases Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70 30 mm length and a vessel diameter of 25 to 35 mm The primary endpoint is late lumen loss after 6 months independent angiographic core lab Secondary endpoints are binary restenosis rate and major adverse cardiac events
Methods and results The PACCOCATH ISR study is a randomized double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR Patients are randomized to rePTCA of ISR either using the coated PTCA balloon 3 µg paclitaxelmm² balloon surface or a non-coated balloon of the same type n56 patients Balloon inflation time is 60 seconds in both cases Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70 30 mm length and a vessel diameter of 25 to 35 mm The primary endpoint is late lumen loss after 6 months independent angiographic core lab Secondary endpoints are binary restenosis rate and major adverse cardiac events
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