A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries - Full Text View

Sponsor:	Boston Scientific Corporation
Information provided by (Responsible Party):	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00896337

Purpose

The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

Condition	Intervention	Phase
Iliac Stenoses	Device: Epic™ Nitinol Stent System	Phase III

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 Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Device- and/or procedure-related major adverse event (MAE)* rate, adjudicated by an independent clinical events committee. [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improvement in Rutherford classification by 1 class as compared to baseline [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: No ]
Frequency distribution of Rutherford classification [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: No ]
Improvement in ABI by 0.1 as compared to baseline. [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: No ]
Target vessel revascularization [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
Target lesion revascularization [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
Amputation of index limb [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
Death [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
Stent thrombosis [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	123
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2013
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ORION All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.	Device: Epic™ Nitinol Stent System The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.

Eligibility

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

Criteria

Inclusion Criteria:

Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4)
Lifestyle-limiting claudication or rest pain
De novo or restenotic lesions in the common and/or external iliac artery
Subjects with bilateral disease may have only one target lesion treated per side
Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)
Length of diseased segment(s) <=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents
Baseline diameter stenosis >= 50% (operator visual assessment)
Reference vessel diameter >= 5 mm and <=11 mm
At least one sufficient ipsilateral infrapopliteal run-off vessel
Origin of profunda femoris artery is patent

Exclusion Criteria:

Target vessel with in-stent restenosis
Acute critical limb ischemia
Tissue loss (Rutherford/Becker category 5 or 6)
Any major amputations to the target limb
Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed.
Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
Platelet count < 150,000 mm3 or > 600,000 mm3
Serum creatinine > 2.0 mg/dL
Dialysis-dependent end stage renal disease
Pregnancy
Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial
Known allergy to Nitinol
Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel
Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography
Target lesion is within or near an aneurysm
Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
Perforated vessel as evidenced by extravasation of contrast media
Vascular graft, aneurysm or postsurgical stenosis of the target vessel
Multiple lesions in the same target vessel unable to be treated with a maximum of two stents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896337

Show 28 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:	Pamela G. Grady, Ph.D.	Boston Scientific Corporation
Principal Investigator:	Daniel G Clair, MD	The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00896337 History of Changes
Other Study ID Numbers:	S2020
Study First Received:	May 8, 2009
Last Updated:	October 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

iliac stenosis
stenosis

Additional relevant MeSH terms:

Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 09, 2012