Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471289
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2007-05-07
Brief Title:
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
Sponsor:
Netherlands Society for Interventional Radiology
Organization:
Netherlands Society for Interventional Radiology
Study Overview
Official Title:
Percutaneous Transluminal Balloon Angioplasty PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PADI
Brief Summary:
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty PTA
Detailed Description:
Critical limb ischemia CLI is a serious condition that is becoming more and more common in the western world due to the growing percentage of elderly in the population and the rising incidence of diabetes In about 40 of patients a stenosis or occlusion in the arteries below the level of the knee will be present Restoration of blood flow is imperative to allow pain relief and tissue healing Without revascularization patients with CLI are at risk for limb loss and potentially fatal complications such as sepsis
In patients treated with percutaneous transluminal balloon angioplasty PTAsignificant restenosis is found in approximately 50 after 6 months
In interventional cardiology a significant reduction in restenosis rates in coronary arteries has been found using drug eluting stents DES including the paclitaxel eluting stent TAXUS Boston Scientific DES locally deliver drugs eg paclitaxel that interfere with the restenosis process
Using DES in treating below the knee infrapopliteal arterial lesions in patients with CLI may improve patency and clinical outcome
Comparison
Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA
In patients treated with percutaneous transluminal balloon angioplasty PTAsignificant restenosis is found in approximately 50 after 6 months
In interventional cardiology a significant reduction in restenosis rates in coronary arteries has been found using drug eluting stents DES including the paclitaxel eluting stent TAXUS Boston Scientific DES locally deliver drugs eg paclitaxel that interfere with the restenosis process
Using DES in treating below the knee infrapopliteal arterial lesions in patients with CLI may improve patency and clinical outcome
Comparison
Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA
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