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Not Yet RecruitingPhase 1ACTRN12608000244303

Evaluation of Safety and Efficacy of the Flexstent Peripheral Stent System in a First in Man Study

Evaluation of Safety and Efficacy of the Flexstent Peripheral Stent System in a First in Man Study in patients with superficial femoral artery diseae.

Sponsor

Flexible Stenting Solutions Inc

Enrollment

10 participants

Start Date

May 1, 2008

Study Type

Interventional

Conditions

Superficial femoral artery disease

Eligibility

Sex: Both males and femalesMin Age: 35 YearssMax Age: 80 Yearss

Inclusion Criteria9

  • Subjects, male or female, must be between the ages of 35 to 80 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
  • Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
  • Rutherford Classification Category 2-4
  • Single de novo lesion in the superficial femoral artery
  • Disease segment length =100mm
  • >50% diameter stenosis and occlusion
  • Patent ipsilateral iliac artery
  • Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
  • Target reference vessel diameter 3.5-5.5 mm

Exclusion Criteria9

  • Target lesion previously treated with a stent or surgery
  • Rutherford Classification Category 0,1,5 or 6
  • Inability to tolerate antithrombotic or antiplatelet therapies
  • Pregnancy
  • Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
  • Serum creatinine >180 mmol/l
  • Myocardial infarction or stroke within 90 days of enrollment
  • Hypercoagulable state
  • Uncontrollable hypertension

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Interventions

A single Flexstent peripheral stent system is implanted in the diseased vessel of the superficial femoral artery using the participating hospital standard procedures. The stents are intended to remai

A single Flexstent peripheral stent system is implanted in the diseased vessel of the superficial femoral artery using the participating hospital standard procedures. The stents are intended to remain in the diseased vessel.

Locations(1)

New Zealand

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ACTRN12608000244303