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

Boston Scientific

Status and phase

Completed

Phase 3

Conditions

Thrombosis

Atherosclerotic Disease

Intermittent Claudication

Arterial Occlusive Disease

Treatments

Device: stent implantation

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00352222

S2015

MTE-E-0301

Details and patient eligibility

About

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).

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 In addition, there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions.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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.