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

Phase 1

• Conditions: Superficial femoral artery disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12608000244303
• Lead Sponsor: Flexible Stenting Solutions Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by in-stent binary restenosis using ultrasound[1, 3, 6, 9, and 12 months.];Safety as measured by adverse events[1, 3, 6, 9, and 12 months.]

Secondary Outcome Measures

Name	Time	Method
Rutherford measurement (scale representing severity of disease)[Pre-treatment, following treatment, 1, 6, and 12 months.];Ankle brachial index[Pre-treatment, after treatment, 1, 6, and 12 months.];Standard treadmill test[Pre-treatment and 6 months];Walking impairment questionnaire[Pre-treatment, 1, 6, and 12 months];Primary, primary assisted, and secondary patency.[1, 6, and 12 months]