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

2014-07-23 21:10:23 | BioPortfolio


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.


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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Peripheral Artery Disease


FlexStent Femoropopliteal Self-Expanding Stent System


Herz-Zentrum Bad Krozingen Abteilung Angiologie
Bad Krozingen




Provascular GmbH

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:10:23-0400

Clinical Trials [2530 Associated Clinical Trials listed on BioPortfolio]

Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Ilia

To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atheros...

Evolution; a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions

The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rut...

The Complete® Self-Expanding Stent and Stent Delivery System Registry

The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified C...

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)

- Prospective, multi-center single-arm observational study - A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be inc...

Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

PubMed Articles [13356 Associated PubMed Articles listed on BioPortfolio]

Management of isolated femoropopliteal in-stent restenosis.

The optimal catheter-directed therapy for femoropopliteal in-stent restenosis (ISR) remains controversial with limited durability. The natural history of untreated ISR is not well characterized. We ev...

Peripheral vascular stent infection: case report and review of literature.

We describe a case of an infected popliteal artery stent with septic emboli presenting 6 years after peripheral vascular intervention for intermittent claudication. Management included resection of th...

Influences of plaque eccentricity and composition on the stent-plaque-artery interaction during stent implantation.

This work aims to investigate the effects of plaque eccentricity and composition on the stent performance and stress distributions of plaque and artery during stenting by the finite element method. Th...

Drug-eluting stent shows similar patency results as prosthetic bypass in patients with femoropopliteal occlusion in a randomized trial.

Claudication and critical limb threatening ischemia (CLTI) are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far consi...

Natural remodeling of the distal anastomosis of an above-knee femoropopliteal bypass depicted by CT angiography of lower limbs improves geometry of the reconstruction.

The geometry of a distal anastomosis of a femoropopliteal bypass influences local hemodynamics and formation of intimal hyperplasia. We hypothesized that the distal anastomosis of an above-knee femoro...

Medical and Biotech [MESH] Definitions

The nervous system outside of the brain and spinal cord. The peripheral nervous system has autonomic and somatic divisions. The autonomic nervous system includes the enteric, parasympathetic, and sympathetic subdivisions. The somatic nervous system includes the cranial and spinal nerves and their ganglia and the peripheral sensory receptors.

Drugs that act principally at one or more sites within the peripheral neuroeffector systems, the autonomic system, and motor nerve-skeletal system. (From Smith and Reynard, Textbook of Pharmacology, 1991, p75)

Insertion of a catheter into a peripheral artery, vein, or airway for diagnostic or therapeutic purposes.


NECROSIS occurring in the ANTERIOR CEREBRAL ARTERY system, including branches such as Heubner's artery. These arteries supply blood to the medial and superior parts of the CEREBRAL HEMISPHERE, Infarction in the anterior cerebral artery usually results in sensory and motor impairment in the lower body.

More From BioPortfolio on "Evaluation of Efficacy and Safety of the FlexStent Self-Expanding Stent System"

Quick Search


Relevant Topic

A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...

Searches Linking to this Trial