Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ 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
Condition: Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Intervention: Omnilink Elite™ Peripheral Balloon-Expandable Stent System
Intervention description: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Atherosclerosis; Peripheral artery disease; Peripheral vascular disease; PAD; Claudication; Peripheral Arterial Occlusive Disease; Stent; PAOD; PVD

Summary:

      To determine the safety and efficacy of the Omnilink Elite™ 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.
    

Eligibility criteria:

        Clinical Inclusion Criteria:

          1. Subject must be at least 18 and < 90 years of age.

          2. Subject has been informed of the nature of the trial, agrees to its provisions, and
             has signed the informed consent form.

          3. Subject must agree to undergo all protocol-required follow-up examinations and
             requirements at the investigational site.

          4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or
             ischemic rest pain (Rutherford Becker Clinical Category 4).

          5. 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.

        Angiographic Inclusion Criteria

          1. 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).

          2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis
             (total occlusion)

          3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis

          4. Lesion length for stenosis of the common or external iliac artery visually estimated
             to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)

          5. Lesion length for total occlusion of the common iliac artery visually estimated to be
             ≤40 mm

          6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm
             (Absolute Pro)

          7. On the treatment side(s), patent superficial femoral and popliteal arteries and at
             least one patent distal outflow artery with in-line distal vessel flow to the foot as
             confirmed by arteriography. Patent is defined as < 50% stenosis.

          8. Lesion length for stenosis of the common or external iliac artery visually estimated
             to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).

          9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm
             (Omnilink Elite).

        Clinical Exclusion Criteria

          1. Subject is unable to walk.

          2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary
             artery bypass graft surgery, thoracic surgery.

          3. Subject has received, or is on the waiting list for a major organ transplant (heart,
             lung, kidney, liver).

          4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.

          5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion
             side(s).

          6. Subject has elevated serum creatinine > 2.0 mg/dl.

          7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).

          8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30
             days.

          9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior
             stroke that limits the subjects ability to walk.

         10. Subject has unstable angina defined as rest angina with ECG changes.

         11. Subject has a groin infection, or an acute systemic infection that is currently under
             treatment.

         12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.

         13. Subject requires any planned procedure within 30 days after the index procedure that
             would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following
             the procedure.

         14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that
             may cause the subject to be non-compliant with protocol requirements, confound the
             data interpretation, or is associated with limited life-expectancy (i.e., less than 2
             years).

         15. Subject is currently participating in an investigational drug or device trial that has
             not completed the primary endpoint follow-up or that clinically interferes with the
             current trial endpoints.

         16. Subject is unable to understand or unwilling to cooperate with trial procedures or is
             unwilling or unable to return to the treatment center for follow-up visits.

         17. If intended stent is Absolute Pro, subject has known hypersensitivity or
             contraindication to nickel, titanium or platinum; subject has known hypersensitivity
             or contraindication to standard intraprocedure anticoagulant(s); subject has
             sensitivity to contrast which cannot be adequately pre-treated with medication.

         18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if
             allergy or contraindication is to clopidogrel, subject is unable to tolerate
             ticlopidine (Ticlid®).

         19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood
             transfusions.

         20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index
             procedure that would interfere with antiplatelet therapy.

         21. If intended stent is Omnilink Elite, subject has known hypersensitivity or
             contraindication to cobalt chromium; subject has known hypersensitivity or
             contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity
             to contrast which cannot be adequately pre-treated with medication.

         22. Requirement of general anesthesia or spinal block for the procedure.

         23. Presence of contralateral limb amputation that was performed to treat any
             non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.

         24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior
             tibial, posterior tibial, peroneal, ipsilateral to the target lesion.

         25. Subject requires a concomitant percutaneous endovascular procedure in another vessel,
             e.g. coronary.

         26. Target lesion is in an iliac artery that has been previously stented.

        Angiographic Exclusion Criteria

          1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to
             the target lesion.

          2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the
             target lesion

          3. Target lesion is within or adjacent to an aneurysm.

          4. Lesion is located within or beyond a vessel that contains a bypass graft.

          5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.

          6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm
             > 3cm.

          7. Lesion extends beyond the inguinal ligament.

          8. Subject has angiographic evidence of thrombus in the target disease segment or vessel
             that is unresponsive to anti-thrombotic therapies.

          9. Subject has multilevel disease in the target extremity that requires other staged
             procedures within 30 days before or after the procedure.

         10. On the treatment side(s), subject is without patent superficial femoral and popliteal
             arteries and at least one patent distal outflow artery with in-line distal vessel flow
             to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.

         11. Requirement for > 1 stent to treat full length of lesion.