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

NCT ID: NCT01071460

Last Updated: 2012-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-02-29

Brief Summary

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.

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.

Conditions

Efficacy of the Study Device

Keywords

PAD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SFA Stenting

Group Type: OTHER

FlexStent Femoropopliteal Self-Expanding Stent System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Provascular GmbH

OTHER

Sponsor Role: lead

Responsible Party

Park Krankenhaus Leipzig

Principal Investigators

Dierk Scheinert, Professor

Role: PRINCIPAL_INVESTIGATOR

Park-Krankenhaus Leipzig

Locations

Herz-Zentrum Bad Krozingen Abteilung Angiologie

Bad Krozingen, , Germany

Jüdisches Krankenhaus Berlin, Gefäßzentrum

Berlin, , Germany

Park-Krankenhaus Leipzig

Leipzig, , Germany

Countries

Germany

Other Identifiers

147-2009-06072009

Identifier Type: OTHER

Identifier Source: secondary_id

Prov 01-2009

Identifier Type: -

Identifier Source: org_study_id