None listed
Conditions
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 remain in the diseased vessel.
Sponsors
Flexible Stenting Solutions Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Rutherford Classification Category 2-4 4. Single de novo lesion in the superficial femoral artery 5. Disease segment length =100mm 6. >50% diameter stenosis and occlusion 7. Patent ipsilateral iliac artery 8. Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle 9. Target reference vessel diameter 3.5-5.5 mm
Exclusion criteria
1. Target lesion previously treated with a stent or surgery 2. Rutherford Classification Category 0,1,5 or 6 3. Inability to tolerate antithrombotic or antiplatelet therapies 4. Pregnancy 5. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up. 6. Serum creatinine >180 mmol/l 7. Myocardial infarction or stroke within 90 days of enrollment 8. Hypercoagulable state 9. Uncontrollable hypertension
Outcome results
None listed