Evaluation of Efficacy and Safety of the FlexStent Self-Expanding Stent System
|ClinicalTrials.gov Identifier: NCT01071460|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : November 9, 2012
Purpose of this registry is to determine the efficacy and safety of the self-expanding, extra flexible FlexStent in patient with superficial femor/popliteal artery disease.
The stent has been developed to cope with the extreme requirements of the femoral artery/knee artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of the femoral- and knee artery.
100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up visits at 6 and 12 month take place.
|Condition or disease||Intervention/treatment||Phase|
|Efficacy of the Study Device||Device: FlexStent Femoropopliteal Self-Expanding Stent System||Phase 3|
Peripheral arterial disease (PAD) represents a major challenge to physicians in treating the Superficial Femoral (SFA) and Popliteal arteries. These arteries represent a harsh environment for any endovascular device. This disease is characterized by long occlusions with relatively low flow and with the vessels exposed to enormous mechanical stress. During flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great ranges of movement while adequately supporting the arteries.
The FlexStent® stent provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel. The intended use for the FlexStent® stent is for the treatment of symptomatic femoropopliteal disease, primarily for atherosclerotic de novo native superficial femoral artery lesions.
The intent of this clinical registry is to demonstrate the efficacy and safety of the FlexStent® stent in patients with superficial femoral/ popliteal artery disease.
Hypothesis: the FlexStent® will be safe and efficacious in treating SFA/popliteal artery diseases.
Primary object: evaluation of efficacy of the FlexStent® measured by the in-stent restenosis using DUS following treatment, 6 and 12 MFU visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The FlexStent-Registry, Evaluation of Efficacy and Safety of the FlexStent Femoropopliteal Self-Expanding Stent System|
|Study Start Date :||November 2009|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Device: FlexStent Femoropopliteal Self-Expanding Stent System
Peri-procedural management will be no different to routine SFA/Popliteal Artery intervention Standard medical therapy
Procedural techniques will be identical to routine protocols for SFA/Popliteal Artery stenting. technique suggested:
- in-stent binary restenosis using DUS [ Time Frame: after treatment, at 6 and 12 MFU ]
- technical success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30% [ Time Frame: at 6 and 12 MFU ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071460
|Herz-Zentrum Bad Krozingen Abteilung Angiologie|
|Bad Krozingen, Germany, 79189|
|Jüdisches Krankenhaus Berlin, Gefäßzentrum|
|Berlin, Germany, 13347|
|Leipzig, Germany, 04289|
|Principal Investigator:||Dierk Scheinert, Professor||Park-Krankenhaus Leipzig|