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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00352222

Collaborator

KIKA (Other)

150

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

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

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 In addition, there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions.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

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Limburgs Vaatcentrum Ziekenhuis Oost-Limburg	Genk		Belgium	3600
2	Sint Trudo Hospital	Sint Truiden		Belgium	3800
3	CHUM- Notre Dame Hospital	Montreal	Quebec	Canada	H2L 4M1
4	General Teaching Hospital Prague	Praha		Czech Republic	12808
5	Institute for Clinical and Experimental Medicine (IKEM)	Praha		Czech Republic	14021
6	Sint Antonius Hospital	Nieuwegein	CM	Netherlands	3435
7	University Hospital of Krakow	Krakow		Poland	31-066
8	University School of Medicine	Lublin		Poland	20-954
9	Center of Diagnostic Imaging and Vascular Disease Treatment	Szczecin		Poland	71-232
10	Samodzielny Publiczny Centraln Szpital	Warszawa		Poland	02-097