Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
Condition: Peripheral Artery Disease; Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Astron Stents; Pulsar Stents
Intervention description: Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.; Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vascular intervention; Endovascular; Peripheral stent

Summary:

      The objective of this study is to separately demonstrate the safety and efficacy of
      BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of
      femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal
      popliteal artery (PPA), while the Astron stent will be used for the treatment of the common
      or external iliac artery lesions.
    

Eligibility criteria:

        Inclusion Criteria

        To support the objectives of this study, the following initial inclusion criteria must be
        met for a subject to be enrolled and considered for the index procedure:

          -  Age ≥ 18 years

          -  Willingness to comply with study follow-up requirements

          -  Candidate for PTA

          -  Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise).
             Thigh brachial index (TBI) may be used / performed if ABI is inadequate.

          -  Written informed consent

        For a subject to receive an investigational stent, the following procedure-related criteria
        must be met:

          -  One de novo, restenotic or occluded lesion representing a femoro-popliteal or iliac
             indication OR Two de novo, restenotic or occluded lesions representing one
             femoro-popliteal indication and one iliac indication on contralateral limbs - (i.e.
             one lesion per limb)

          -  Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated
             as one lesion

          -  Subjects with bilateral, SFA/PPA disease (i.e. one SFA/PPA lesion per limb) are
             eligible for enrollment into the study. The target lesion will be selected at the
             investigator's discretion based on study eligibility criteria. The contralateral
             SFA/PPA intervention may be performed at the time of the index procedure (prior to
             treatment of study lesion); however, the use of an investigational treatment is
             prohibited. If the contralateral SFA/PPA intervention is not performed at the time of
             the index procedure, the intervention must be performed at least 30 days after the
             index procedure. The use of an investigational treatment for the contralateral
             intervention is prohibited.

          -  Subjects with bilateral, iliac disease (i.e. one iliac lesion per limb) are eligible
             for enrollment into the study. The target lesion will be selected at the
             investigator's discretion based on study eligibility criteria. The contralateral iliac
             intervention may be performed at the time of the index procedure; however, the use of
             an investigational treatment is prohibited. If the contralateral iliac intervention is
             not performed at the time of the index procedure, the intervention must be performed
             at least 30 days after the index procedure. The use of an investigational treatment
             for the subsequent contralateral intervention is also prohibited.

          -  Femoro-popliteal lesions must be located at least 1 cm distal to the profunda femoris
             artery and at least 3 cm above the knee joint (radiographic joint space)

          -  Iliac lesions must be located only in either the common or external iliac artery

          -  Lesions must be treatable with a maximum of two stents

          -  Angiographic evidence of ≥ 70% stenosis or occlusion (operator visual assessment)

          -  Lesion length ≤ 190 mm (if de novo or restenotic) or ≤ 100 mm (if occluded)

          -  Target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) or 6 to 9 mm (iliac arteries)
             by visual estimate

          -  Angiographic evidence of patent SFA and PPA (iliac indication) and angiographic
             evidence of at least one distal vessel runoff to the foot (both femoro-popliteal and
             iliac indications). Patent is defined as < 50% stenosis.

          -  For SFA/PPA intervention, a significant stenosis (> 70%) or occlusion of an
             ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully
             treated (use of investigational treatment prohibited) just prior to treatment of the
             target lesion. Successful treatment is defined as no complications and less than 30%
             residual stenosis following intervention.

        Exclusion Criteria

        To support the objectives of this study, the following initial exclusion criteria must not
        be present for a subject to be enrolled:

          -  Subjects pregnant or planning to become pregnant during the course of the study

          -  Life expectancy of less than one year

          -  Rutherford-Becker category 5 or 6. Subjects with ulcers caused by venous disease may
             be enrolled in the study.

          -  Previously stented lesion(s) in the target vessel

          -  Target lesion(s) received previous treatment within 30 days prior to enrollment

          -  Prior peripheral vascular bypass surgery involving the target limb(s)

          -  Thrombophlebitis or deep vein thrombosis within the past 30 days

          -  Known allergy to nitinol (nickel and/or titanium)

          -  Participation in any other clinical investigational device or drug study. Subjects may
             be concurrently enrolled in a post-market study, as long as the post-market study
             device, drug or protocol does not interfere with the investigational treatment or
             protocol of this study.

          -  Previous stroke or transient ischemic attack within the last three months prior to
             enrollment

          -  Previous coronary or peripheral bypass surgery (non-target limb) within 30 days prior
             to enrollment

          -  Intolerance to contrast agents that cannot be medically managed and/or intolerance to
             anti-platelet, anti-coagulant or thrombolytic medications

          -  Refuses blood transfusions

          -  Any medical condition, that in the opinion of the investigator, poses an unacceptable
             risk for implant of a stent according to the study indications

        For a subject to receive an investigational stent the following procedure-related criteria
        must not be present:

          -  INR ≥ 1.6

          -  Concomitant renal failure with serum creatinine level > 2.5 mg/dL

          -  Unresolved neutropenia (white blood cell count < 3,000 / µL) or thrombocytopenia
             (platelet count < 80,000 / µL) at the time of the index procedure

          -  Unresolved bleeding disorder (INR ≥ 1.6) at the time of the index procedure

          -  Presence of other ipsilateral, arterial lesions distal to the target lesion requiring
             treatment within 30 days of the index procedure (either before or after) or at the
             time of the index procedure

          -  Additional percutaneous interventional procedures (cardiac and/or peripheral) planned
             within 30 days after the index procedure

          -  Presence of a complication following pre-dilation of target lesion

          -  Presence of a target vessel/lesion that is excessively tortuous or calcified or is
             adjacent to an acute thrombus that is unresponsive to anti-thrombotic therapies

          -  Target lesion is located within an aneurysm or associated with an aneurysm in the
             vessel segment either proximal or distal to the target lesion

          -  Target lesion requires the use of cutting balloons, atherectomy or ablative devices

          -  Subjects with less than single vessel runoff to the foot