Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352222
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
2006-07-12
Brief Title:
Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Prospective Multicenter Single Arm Study to Obtain Additional Data on the Safety and Efficacy of the Express Vascular LD Implantation in the Treatment of Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries
Status:
COMPLETED
Status Verified Date:
2008-09
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:
MELODIE
Brief Summary:
To obtain additional data on safety and efficacy of the Express stent implantation in the treatment of stenosed or occlusive atherosclerotic disease de novo or restenotic lesions in the iliac arteries common or external
Detailed Description:
This study was conducted to provide additional data on the safety and efficacy of the Express Vascular LD stent particularly with regard to the long-term patency in iliac arteries The study would provide data on angiographic endpoints and clinical outcomes at 30 days 6 months and at 12 and 24 months post implantation in atherosclerotic lesions in iliac arteries The data obtained in this study with the use of the Express Vascular LD stent was compared with historical data obtained from the use of the Palmaz balloon-expandable stent The Palmaz balloon expandable stent has been chosen as the control device because it is currently the only FDA-approved balloon-expandable stent for use in the percutaneous treatment of atherosclerotic disease in iliac arteries
The Palmaz balloon-expandable stent is no longer commercialized in Europe Therefore a randomized study with the Palmaz balloon-expandable stent was not feasible In addition there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions In order to adequately compare the efficacy data of the ExpressTM Vascular LD stent with the efficacy data of the Palmaz balloon-expandable stent the same efficacy parameter as in the publication on the Palmaz balloon-expandable stent was measured in this study mean loss of the luminal diameter at 6 months post-procedure
The findings of the longer-term Follow-Up assessments at 12 and 24 months will be presented as the results from these assessments become available
The Palmaz balloon-expandable stent is no longer commercialized in Europe Therefore a randomized study with the Palmaz balloon-expandable stent was not feasible In addition there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions In order to adequately compare the efficacy data of the ExpressTM Vascular LD stent with the efficacy data of the Palmaz balloon-expandable stent the same efficacy parameter as in the publication on the Palmaz balloon-expandable stent was measured in this study mean loss of the luminal diameter at 6 months post-procedure
The findings of the longer-term Follow-Up assessments at 12 and 24 months will be presented as the results from these assessments become available
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 |
|---|---|---|---|
| MTE-E-0301 | None | None | None |