Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Sten… (NCT01396525) | Clinical Trial Compass
CompletedPhase 3
Trial to Evaluate the Safety & Efficacy of the Omnilink Eliteâ„¢ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery
United States153 participantsStarted 2009-03
Plain-language summary
To determine the safety and efficacy of the Omnilink Eliteâ„¢ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. Subject must be at least 18 and \< 90 years of age.
✓. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
✓. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
✓. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
✓. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.
✓. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).
✓. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)
✓. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis
Exclusion criteria
✕. Subject is unable to walk.
✕. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.