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

This study has been completed.
Sponsor:
Collaborator:
KIKA
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00352222
First received: July 12, 2006
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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).


Condition Intervention Phase
Arterial Occlusive Disease
Intermittent Claudication
Atherosclerotic Disease
Thrombosis
Device: stent implantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Boston Scientific Corporation:

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

Estimated Enrollment: 150
Study Start Date: January 2004
Study Completion Date: February 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352222

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

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Cornaille, Boston Scientific
ClinicalTrials.gov Identifier: NCT00352222     History of Changes
Other Study ID Numbers: S2015, MTE-E-0301
Study First Received: July 12, 2006
Last Updated: September 25, 2008
Health Authority: Netherlands: Independent Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Boston Scientific Corporation:
iliac arteries
implantation
treatment of atherosclerotic disease
stenosed
occlusive

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Intermittent Claudication
Thrombosis
Arteriosclerosis
Cardiovascular Diseases
Embolism and Thrombosis
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014