Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473772
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2007-05-14
Brief Title:
DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2014-05
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:
PEPCADIII
Brief Summary:
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system DEBlue in the treatment of stenoses in native coronary arteries with nominal stent diameters between 25 mm and 35 mm and 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent
Detailed Description:
The incidence of in-stent restenosis after percutaneous coronary intervention varies between 5 and 35 after bare metal stenting and is as high as 19 after the implantation of a drug-eluting stent in patients at moderate risk Restenosis due to neointimal hyperplasia is a slow process suggesting that therapeutic local drug administration would need to be prolonged to be beneficial Stent-based local drug delivery provides sustained drug release using special release technologies like polymer coating However cell culture experiments indicate that even brief contact between vascular smooth muscle cells and lipophilic taxane compounds can inhibit vascular smooth muscle cell proliferation for a long period In experiments in swine intracoronary delivery of paclitaxel by contrast media or by a drug-coated balloon catheter was found to result in vascular tissue concentrations capable of producing antiproliferative effects thus leading to a significant reduction in neointimal proliferation In these animal studies the most pronounced reduction of neointimal formation was seen with paclitaxel-coated balloon catheters
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