Clinical trial NCT00896337: EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Official title: A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iliac Artery Stenosis
Keywords: iliac artery stenosis
claudication
atherosclerotic iliac disease
peripheral vascular disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-05-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

Eligibility 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

Primary outcomes:
measure: Device- and/or Procedure-related Major Adverse Events (MAE)
timeFrame: 9 Months
Secondary outcomes:
measure: Death
timeFrame: 30 Days
measure: Death
timeFrame: 9 Months
measure: Death
timeFrame: 1 Year
measure: Death
timeFrame: 2 Years
measure: Death
timeFrame: 3 Years
measure: Amputation of Index Limb
timeFrame: 9 Months
measure: Amputation of Index Limb
timeFrame: 1 Year
measure: Amputation of Index Limb
timeFrame: 2 Years
measure: Amputation of Index Limb
timeFrame: 3 Years
measure: Target Vessel Revascularization (TVR)
timeFrame: 30 Days
measure: Target Vessel Revascularization (TVR)
timeFrame: 9 Months
measure: Target Vessel Revascularization (TVR)
timeFrame: 1 Year
measure: Target Vessel Revascularization (TVR)
timeFrame: 2 Years
measure: Target Vessel Revascularization (TVR)
timeFrame: 3 Years
measure: Myocardial Infarction (MI)
timeFrame: Index hospitalization
measure: Technical Success
timeFrame: Index procedure
measure: Procedure Success
timeFrame: In hospital (1-2 days post procedure)
measure: Early Clinical Success
timeFrame: Hospital Discharge
measure: Early Clinical Success
timeFrame: 30 Days
measure: Late Clinical Success
timeFrame: 9 Months
measure: Late Clinical Success
timeFrame: 1 Year
measure: Early Hemodynamic Success
timeFrame: Hospital Discharge
measure: Early Hemodynamic Success
timeFrame: 30 Days
measure: Late Hemodynamic Success
timeFrame: 9 Months
measure: Late Hemodynamic Success
timeFrame: 1 Year
measure: Rutherford Classification Distribution
timeFrame: Pre-procedure/baseline
measure: Rutherford Classification Distribution
timeFrame: Post-procedure
measure: Rutherford Classification Distribution
timeFrame: 30 Days
measure: Rutherford Classification Distribution
timeFrame: 9 Months
measure: Rutherford Classification Distribution
timeFrame: 1 Year
measure: Acute Stent Thrombosis
timeFrame: 24 Hours
measure: Sub-acute Stent Thrombosis
timeFrame: >24 Hours to <=30 Days Post-index procedure
measure: Stent Thrombosis
timeFrame: 9 Months
measure: Stent Thrombosis
timeFrame: 1 Year
measure: Stent Thrombosis
timeFrame: 2 Years
measure: Stent Thrombosis
timeFrame: 3 Years
measure: Target Lesion Revascularization (TLR)
timeFrame: 30 Days
measure: Target Lesion Revascularization (TLR)
timeFrame: 9 Months
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 Year
measure: Target Lesion Revascularization (TLR)
timeFrame: 2 Years
measure: Target Lesion Revascularization (TLR)
timeFrame: 3 Years
measure: Ankle-Brachial Index (ABI)
timeFrame: Pre-procedure/baseline
measure: Ankle-Brachial Index
timeFrame: Hospital Discharge (1-2 days post-procedure)
measure: Ankle-Brachial Index (ABI)
timeFrame: 30 Days
measure: Ankle-Brachial Index (ABI)
timeFrame: 9 Months
measure: Ankle-Brachial Index (ABI)
timeFrame: 1 Year
measure: Primary Patency
timeFrame: 9 Months
measure: Primary Patency
timeFrame: 1 Year
measure: Primary-assisted Patency (PAP)
timeFrame: 9 Months
measure: Primary-assisted Patency (PAP)
timeFrame: 1 Year
measure: Secondary Patency
timeFrame: 9 Months
measure: Secondary Patency
timeFrame: 1 Year
measure: Restenosis Assessed by Duplex Ultrasound
timeFrame: 9 Months
measure: Restenosis Assessed by Duplex Ultrasound
timeFrame: 1 Year
measure: Walking Impairment Questionnaire Score - Distance
timeFrame: Pre-procedure/baseline
measure: Walking Impairment Questionnaire Score - Distance
timeFrame: 9 Months
measure: Walking Impairment Questionnaire Score - Distance
timeFrame: 1 Year
measure: Walking Impairment Questionnaire Score - Speed
timeFrame: Pre-procedure/baseline
measure: Walking Impairment Questionnaire Score - Speed
timeFrame: 9 Months
measure: Walking Impairment Questionnaire Score - Speed
timeFrame: 1 Year
measure: Walking Impairment Questionnaire Score-Stair Climbing
timeFrame: Pre-procedure/baseline
measure: Walking Impairment Questionnaire Score - Stair Climbing
timeFrame: 9 Months
measure: Walking Impairment Questionnaire Score - Stair Climbing
timeFrame: 1 Year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: St. Joseph's Hospital
state: Arizona
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Ocala
country: United States
facility: Mediquest Research at Munroe Regional Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital-Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Davenport
country: United States
facility: Trinity Terrace Park
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Robbinsdale
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology - Presbyterian Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Fargo
country: United States
facility: MeritCare Hospital
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: UPMC - Shadyside Hospital
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: San Antonio
country: United States
facility: Baptist Hospital of San Antonio
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: Boston Scientific Corporation
name: Pamela G. Grady, Ph.D.
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Daniel G Clair, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clair DG, Adams J, Reen B, Feldman R, Starr J, Diaz-Cartelle J, Dawkins KD. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial. J Endovasc Ther. 2014 Apr;21(2):213-22. doi: 10.1583/13-4560.1.