Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries (MELODIE)

September 25, 2008 updated by: Boston Scientific Corporation

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 In addition, there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions.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.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Limburgs Vaatcentrum Ziekenhuis Oost-Limburg
      • Sint Truiden, Belgium, 3800
        • Sint Trudo Hospital
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM- Notre Dame Hospital
  • Czech Republic
      • Praha, Czech Republic, 12808
        • General Teaching Hospital Prague
      • Praha, Czech Republic, 14021
        • Institute for Clinical and Experimental Medicine (IKEM)
  • Netherlands
    • CM
      • Nieuwegein, CM, Netherlands, 3435
        • Sint Antonius Hospital
  • Poland
      • Krakow, Poland, 31-066
        • University Hospital of Kraków
      • Lublin, Poland, 20-954
        • University School of Medicine
      • Szczecin, Poland, 71-232
        • Center of Diagnostic Imaging and Vascular Disease Treatment
      • Warszawa, Poland, 02-097
        • Samodzielny Publiczny Centraln Szpital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic symptomatic atherosclerotic disease in the iliac arteries (Fontaine Class IIa, IIb, and III)
  • atherosclerotic de novo or restenotic lesions in the common and/or external iliac artery.
  • baseline diameter stenosis of > or = 50%
  • reference vessel diameter > or = 5mm and < or = 10mm
  • at least one sufficient ipsilateral infrapopliteal run-off
  • length of diseased segment(s) < or = 10cm and can be treated with maximally two overlapping Express Vascular LD Stents.
  • multiple target lesions of the iliac arteries in the same patient can be included provided if each target lesion is compliant with the antiographic inclusion criteria and non-compliant with any of the antiographic exclusion criteria, target lesions are not located in the same target axis, and all target lesions can be treated during the same procedure.

Exclusion Criteria:

  • chronic symptomatic atherosclerotic disease classified as fontaine Class I or IV
  • acute leg ischemia
  • pregnants patients
  • patients with uncorrected bleeding disorders (platelets < 150 000/mm3 or > 450 000 mm3, or patient who cannot receive anticoagulation or antiplatelet aggregation therapy
  • patient with known allergy to stainless steel
  • known anaphylactoid or other non-anaphylactic reactions to contrast agents that cannot be adequately premedicated prior to the index procedure
  • life-expectancy of less than 24 months due to other medical co-morbid condition that could limit patient's ability to participate in the study, the patient's compliance with the follow-up requirements or impact the scientific integrity of the study
  • patient currently participating in another study that has not yet completed the primary endpoint or that clinically interferes with the endpoint of this study
  • patients who have already participated in this study
  • patients with prior or planned bypass surgery of the target vessel
  • patient with prior stent placement in the target vessel
  • patient with any previous coronary intervention within the last 30 days before enrollment into this study or patients with planned coronary intervention within 30 days after enrollment into this study.
  • patients in whom the origin of the profunda femoris and superficial femoral artery is occluded in the limb supplied by the iliac artery to be treated without planned surgical repair
  • patients with heavily calcified and excessive tortuous lesions at the target site as determined by angiography
  • patients with target lesion which is within or adjacent to the proximal or distal segment of an aneurysm
  • patients with persistent, acute intraluminal thrombus of the proposed target lesion site post-thrombolytic therapy
  • patients with perforated vessels as evidenced by extravasation of contrast media
  • patients with multiple lesions in the same target vessels.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
hemodynamic success at hospital discharge, 30 days and 6, 12 and 24 months post-procedure, angiographic binary restenosis at 6 mont

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

KIKA

Investigators

  • Principal Investigator: Luc Stockx, MD, Limburgs Vaatcentrum Ziekenhuis Oost-Limburg, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2015
  • MTE-E-0301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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