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

The FlexStent-Registry, Evaluation of Efficacy and Safety of the FlexStent Femoropopliteal Self-Expanding Stent System

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.

Study Overview

• Status: Completed
• Conditions: Efficacy of the Study Device
• Intervention / Treatment: Device: FlexStent Femoropopliteal Self-Expanding Stent System

Detailed Description

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
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Herz-Zentrum Bad Krozingen Abteilung Angiologie
  • Berlin, Germany, 13347
    • Jüdisches Krankenhaus Berlin, Gefäßzentrum
  • Leipzig, Germany, 04289
    • Park-Krankenhaus Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects, male or female, must be between the ages of 35 to 85 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at 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
• Single de novo lesion in the superficial femoro/popliteal artery

• Disease segment length ≤150mm

  ->70% diameter stenosis and occlusion

• Patent ipsilateral iliac artery
• Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
• Target reference vessel diameter 3.5-7.5 mm

Exclusion Criteria:

• Target lesion previously treated with a stent or surgery.
• Rutherford Classification Category 0,1,5 or 6.
• Inability to tolerate antithrombotic or antiplatelet therapies.
• Pregnancy.
• 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 90 days of enrollment.
• Hypercoagulable state.
• Uncontrollable hypertension.
• Patients currently enrolled in any other clinical trial(s).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: SFA Stenting

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: Contralateral retrograde common femoral cross-over access or antegrade access; Target lower limb arteries fully imaged angiogram. with measurement of SFA/Popliteal Artery target lesion length and normal vessel diameter immediately above and below target lesion; Pre-stenting balloon dilatation of target lesion in all total occlusions and critical stenosis; Deployment of an appropriately sized FlexStent® to cover target lesion; Post-stent balloon dilate stent using a semi-compliant angioplasty balloon to enable accurate post-dilatation of stent to target diameter; Post stenting angiography assessing target lesion parameters, run-off vessel patency and complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
in-stent binary restenosis using DUS	after treatment, at 6 and 12 MFU

Secondary Outcome Measures

Outcome Measure	Time Frame
technical success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%	at 6 and 12 MFU

Collaborators and Investigators

• Sponsor: Provascular GmbH
• Investigators: Principal Investigator: Dierk Scheinert, Professor, Park-Krankenhaus Leipzig

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 8, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: PAD
• Other Study ID Numbers: Prov 01-2009; 147-2009-06072009 (Other Identifier: Ethic Committee at the University of Leipzig, Germany)