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Arterial Occlusive DiseasePhase 3MELODIENCT00352222

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

A Phase 3 study testing stent implantation in people with Arterial Occlusive Disease and Intermittent Claudication, run by Boston Scientific Corporation at 10 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
stent implantation
Type of treatment
Medical device
How many people
150 participants
Where
10 sitesin 5 countries
Study dates
Jan 2004to Feb 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

10 sites in 5 countries.

10 sites in 5 countries

Poland4 sites

  • University Hospital of Krakow

    Krakow, 31-066

  • University School of Medicine

    Lublin, 20-954

  • Center of Diagnostic Imaging and Vascular Disease Treatment

    Szczecin, 71-232

  • Samodzielny Publiczny Centraln Szpital

    Warsaw, 02-097

Other trials in Poland

Belgium2 sites

  • Limburgs Vaatcentrum Ziekenhuis Oost-Limburg

    Genk, 3600

  • Sint Trudo Hospital

    Sint-Truiden, 3800

Other trials in Belgium

Czechia2 sites

  • General Teaching Hospital Prague

    Prague, 12808

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague, 14021

Other trials in Czechia

Canada1 site

  • CHUM- Notre Dame Hospital

    Montreal, Quebec, H2L 4M1

Other trials in Canada

Netherlands1 site

  • Sint Antonius Hospital

    Nieuwegein, CM, 3435

Other trials in Netherlands

About this study

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

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).

Read the 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.

Being tested
stent implantation
Keywords
iliac arteries, implantation, treatment of atherosclerotic disease, stenosed, occlusive
Medical subject headings
Arterial Occlusive Diseases, Intermittent Claudication, Thrombosis, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stent implantationDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2006 (estimated)
  2. Study startJan 2004
  3. Primary completionJul 2005
  4. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352222
Sponsor's protocol ID
S2015
Other IDs
MTE-E-0301
Acronym
MELODIE
Status last verified
Sep 2008
First submitted
12 Jul 2006
Last updated
29 Sep 2008
Results posted
No

Publications

  • Stockx L, Poncyljusz W, Krzanowski M, Schroe 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. doi: 10.1583/09-2917MR.1.

    PubMed 20939723

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing stent implantation in people with Arterial Occlusive Disease and Intermittent Claudication, run by Boston Scientific Corporation at 10 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Poland, Belgium, Czechia, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00352222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2008.

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