Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.

The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases PAD Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Disease Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imelda Hospital / Flanders Medical Research Program, Bonheiden, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All subjects must meet the following criteria:

Subjects, male or female, must be at least 35 years of age at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of 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
De novo lesion in the Femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint
Disease segment length ≤ 180 mm
>70% diameter stenosis and/or occlusion based on site-determined visual angiography
Patent ipsilateral iliac artery
Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention
Target reference vessel diameter 3.5-7.5 mm.
Projected life expectancy of 12 months or greater
Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements
Patient is willing and able to provide signed informed consent

Exclusion criteria

Any subject meeting any of the following criteria will be excluded from the study.

Target vessel previously treated with a stent
Target lesion within 1.5 cm of the ostium of the SFA
Rutherford Classification Category 0,1,5 or 6
Inability to tolerate antithrombotic or antiplatelet therapies
Pregnancy (female of child-bearing age confirmed pregnant)
Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
Serum creatinine > 2.5 mg/dL
Myocardial infarction or stroke within 30 days of treatment date
Known hypercoagulable state
Known bleeding diathesis
Untreated angiographically-evident thrombus in target vessel
Patients currently enrolled in any other clinical trial

Treatment and study plan

FlexStent® Femoropopliteal Self Expanding Stent System

Device

Transcatheter over guidewire placement of an intravascular stent(s)

Other names: FlexStent®, OPEN

Primary outcomes

The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days.

Time frame: 30 Days

The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents.
The primary efficacy endpoint is vessel patency at 12 months.

Time frame: 12 Months

The primary efficacy endpoint is vessel patency at 12 months. Vessel patency is defined as freedom from a greater than 50% restenosis in the stented segment as determined by the DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the proximal normal arterial segment and freedom from clinically-driven TLR within the stented segment within 1 year of the procedure.

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Collaborators

Massachusetts General Hospital
Prairie Education and Research Cooperative

Registry information

Official study title

Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study

Acronym: OPEN

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2018
First posted: May 18, 2011
Registry last updated: Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed