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


Eligibility

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

Plain Language Summary

Simplified for easier understanding

This study is looking at evaluation of Safety and Efficacy of the Flexstent Peripheral Stent System in a First in Man Study. It is open to both men and women, aged 35 to 80. People with certain health conditions such as 1. target lesion previously treated with a stent or surgery may not be able to join. If you take part, the research team will explain what is involved and monitor your health throughout the study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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