Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393315
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2006-10-26
Brief Title:
P E P C A D II The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
P E P C A D II The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses A Comparison to the Paclitaxel-Eluting Taxus Stent A Pilot Study
Status:
COMPLETED
Status Verified Date:
2010-06
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 aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with reference diameters between 25 mm and 35 mm and 22 mm in length for procedural success and preservation of vessel patency in comparison to the Paclitaxel-eluting Taxus stent
Detailed Description:
Background information
Stent deployment for the treatment of coronary artery stenoses has evolved as the standard treatment in nearly all types of coronary lesions over the past two decadesThe initial recurrence rate of bare stents in the range of 20 30 in low risk stenoses has been further reduced by devices with passive coatings such as silicon carbide heparin phosphorylcholine and carbon The significant decline of in-stent restenoses ISR to the order of 12 was achieved by active coatings like the cell-cycle inhibitor sirolimus and to about 137 by the cytotoxic paclitaxel Taken into account the more than one million annual stent procedures performed worldwide even low recurrence rates will leave some hundred thousand repeat procedures annually In the treatment of in-stent restenoses however approaches such as stand alone angioplasty with conventional balloons the repeat use of bare stents cutting balloon angioplasty rotablation and atherectomy have revealed unsatisfactory and often conflicting results For brachytherapy the late loss was reported in the range from 022 - 084 mm to 073 - 079mm Due to its disadvantages such as delayed endothelialization with ensuing late thrombosis cumulating in a 12-months cardiac event rate of up to 30 rising to 50 after five years its decrease of benefit over time and the cumbersome logistics at the sites and in the labs brachytherapy is not considered as a valid approach of the future Recently the deployment of drug eluting stents into a restenotic device was associated with restenosis rates in the range from 4 to 30 suggesting some advantage over the aforementioned approaches The wide range of the results and some late cardiac events still leave room for alternative methods such as the Paclitaxel-eluting PTCA balloon catheter
Study Rationale The principle of the Paclitaxel-eluting PTCA balloon catheter is based on the antiproliferative mode of action of the compound the latter being homogenously distributed along the entire length of the balloon and hence the vessel segment to be treated This advantage is in particular relevant in comparison to drug eluting stents as are the lack of chronic mechanical alterations of the artery the ease of access to the lesion the obviation of adding another layer of metal to the lesion and the presumably lower cost of the procedure Data on the use of the Paclitaxel-eluting PTCA balloon catheter on the treatment of in-stent restenoses however are scant In the animal model and according to unpublished results in humans the proliferation induced by a Paclitaxel-eluting balloon catheter was significantly less compared to an uncoated balloon and to the Sirolimus-eluting Cypher stentTherefore it is prudent to compare the direct arterial application of Paclitaxel by means of the Paclitaxel-eluting PTCA balloon catheter versus the Paclitaxel-eluting Taxus-stent as percutaneous transluminal treatment options of in-stent restenosis in human coronary arteries in a prospective randomized pilot study
Stent deployment for the treatment of coronary artery stenoses has evolved as the standard treatment in nearly all types of coronary lesions over the past two decadesThe initial recurrence rate of bare stents in the range of 20 30 in low risk stenoses has been further reduced by devices with passive coatings such as silicon carbide heparin phosphorylcholine and carbon The significant decline of in-stent restenoses ISR to the order of 12 was achieved by active coatings like the cell-cycle inhibitor sirolimus and to about 137 by the cytotoxic paclitaxel Taken into account the more than one million annual stent procedures performed worldwide even low recurrence rates will leave some hundred thousand repeat procedures annually In the treatment of in-stent restenoses however approaches such as stand alone angioplasty with conventional balloons the repeat use of bare stents cutting balloon angioplasty rotablation and atherectomy have revealed unsatisfactory and often conflicting results For brachytherapy the late loss was reported in the range from 022 - 084 mm to 073 - 079mm Due to its disadvantages such as delayed endothelialization with ensuing late thrombosis cumulating in a 12-months cardiac event rate of up to 30 rising to 50 after five years its decrease of benefit over time and the cumbersome logistics at the sites and in the labs brachytherapy is not considered as a valid approach of the future Recently the deployment of drug eluting stents into a restenotic device was associated with restenosis rates in the range from 4 to 30 suggesting some advantage over the aforementioned approaches The wide range of the results and some late cardiac events still leave room for alternative methods such as the Paclitaxel-eluting PTCA balloon catheter
Study Rationale The principle of the Paclitaxel-eluting PTCA balloon catheter is based on the antiproliferative mode of action of the compound the latter being homogenously distributed along the entire length of the balloon and hence the vessel segment to be treated This advantage is in particular relevant in comparison to drug eluting stents as are the lack of chronic mechanical alterations of the artery the ease of access to the lesion the obviation of adding another layer of metal to the lesion and the presumably lower cost of the procedure Data on the use of the Paclitaxel-eluting PTCA balloon catheter on the treatment of in-stent restenoses however are scant In the animal model and according to unpublished results in humans the proliferation induced by a Paclitaxel-eluting balloon catheter was significantly less compared to an uncoated balloon and to the Sirolimus-eluting Cypher stentTherefore it is prudent to compare the direct arterial application of Paclitaxel by means of the Paclitaxel-eluting PTCA balloon catheter versus the Paclitaxel-eluting Taxus-stent as percutaneous transluminal treatment options of in-stent restenosis in human coronary arteries in a prospective randomized pilot study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PEPCAD IICRI05-02c-c | None | None | None |