EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

NCT ID: NCT00896337

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Iliac Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Epic™ Nitinol Stent System

Intervention Type: DEVICE

The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.

Anti-platelet therapy

Intervention Type: DRUG

Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.

Anti-coagulation therapy

Intervention Type: DRUG

Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Interventions

Epic™ Nitinol Stent System

The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.

Intervention Type: DEVICE

Anti-platelet therapy

Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.

Intervention Type: DRUG

Anti-coagulation therapy

Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela G. Grady, Ph.D.

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Daniel G Clair, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

St. Joseph's Hospital

Tucson, Arizona, United States

Brandon Regional Hospital

Brandon, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Mediquest Research at Munroe Regional Medical Center

Ocala, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Parkview Hospital-Parkview Research Center

Fort Wayne, Indiana, United States

St. Vincent's Hospital

Indianapolis, Indiana, United States

Trinity Terrace Park

Davenport, Iowa, United States

University of Michigan

Ann Arbor, Michigan, United States

North Memorial Medical Center

Robbinsdale, Minnesota, United States

Mount Sinai Medical Center

New York, New York, United States

Mid-Carolina Cardiology - Presbyterian Hospital

Charlotte, North Carolina, United States

Wake Medical Center

Raleigh, North Carolina, United States

MeritCare Hospital

Fargo, North Dakota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

UPMC - Shadyside Hospital

Pittsburgh, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

St. Thomas Research Institute

Nashville, Tennessee, United States

VA North Texas Health Care System

Dallas, Texas, United States

Baptist Hospital of San Antonio

San Antonio, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24754280 (View on PubMed)

Other Identifiers

S2020

Identifier Type: -

Identifier Source: org_study_id