Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries (MELODIE)
Tracking Information | |||||
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First Received Date ICMJE | July 12, 2006 | ||||
Last Updated Date | September 25, 2008 | ||||
Start Date ICMJE | January 2004 | ||||
Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Angiographic mean percent loss of luminal diameter at 6 months post-procedure defined as ((post-procedure MLD - Follow-up MLD)/Post-procedure MLD) X 100 | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00352222 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
hemodynamic success at hospital discharge, 30 days and 6, 12 and 24 months post-procedure, angiographic binary restenosis at 6 mont | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries | ||||
Official Title ICMJE | 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 | ||||
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). |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: stent implantation | ||||
Study Arm (s) | |||||
Publications * | Stockx L, Poncyljusz W, Krzanowski M, Schroë H, Allocco DJ, Dawkins KD; MELODIE Investigators. Express LD vascular stent in the treatment of iliac artery lesions: 24-month results from the MELODIE trial. J Endovasc Ther. 2010 Oct;17(5):633-41. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 150 | ||||
Completion Date | February 2007 | ||||
Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Belgium, Canada, Czech Republic, Netherlands, Poland | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352222 | ||||
Other Study ID Numbers ICMJE | S2015, MTE-E-0301 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Anne Cornaille, Boston Scientific | ||||
Study Sponsor ICMJE | Boston Scientific Corporation | ||||
Collaborators ICMJE | KIKA | ||||
Investigators ICMJE |
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Information Provided By | Boston Scientific Corporation | ||||
Verification Date | September 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |