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

NCT00352222 | Completed Phase 3

• 2 other identifiers: S2015MTE-E-0301
• Study Type: interventional
• Target: 150
• Locations: 5 countries
• Sites: 10

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).

Conditions

Arterial Occlusive Disease; Intermittent Claudication; Atherosclerotic Disease; Thrombosis

Keywords

iliac arteries; implantation; treatment of atherosclerotic disease; stenosed; occlusive

Outcome Measures

Primary Outcomes (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)

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

Interventions

stent implantation DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• KIKA: collaborator

Study Sites (10)

Limburgs Vaatcentrum Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Sint Trudo Hospital

Sint-Truiden, 3800, Belgium

Location

CHUM- Notre Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

Location

General Teaching Hospital Prague

Prague, 12808, Czechia

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14021, Czechia

Location

Sint Antonius Hospital

Nieuwegein, CM, 3435, Netherlands

Location

University Hospital of Krakow

Krakow, 31-066, Poland

Location

University School of Medicine

Lublin, 20-954, Poland

Location

Center of Diagnostic Imaging and Vascular Disease Treatment

Szczecin, 71-232, Poland

Location

Samodzielny Publiczny Centraln Szpital

Warsaw, 02-097, Poland

Location

Related Publications (1)

• 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.

  PMID: 20939723 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases; Intermittent Claudication; Thrombosis; Bites and Stings

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Luc Stockx, MD

  Limburgs Vaatcentrum Ziekenhuis Oost-Limburg, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: January 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: February 1, 2007
• Last Updated: September 29, 2008

Record last verified: 2008-09

Locations

PL (4); CZ (2); BE (2); NL (1); CA (1)