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

NCT01071460 | Completed Phase 3 DMC

• 2 other identifiers: Prov 01-2009147-2009-06072009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Efficacy of the Study Device

Keywords

PAD

Outcome Measures

Primary Outcomes (1)

• in-stent binary restenosis using DUS

  after treatment, at 6 and 12 MFU

Secondary Outcomes (1)

• technical success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%

  at 6 and 12 MFU

Study Arms (1)

SFA Stenting

OTHER

Device: FlexStent Femoropopliteal Self-Expanding Stent System

Interventions

FlexStent Femoropopliteal Self-Expanding Stent System 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

SFA Stenting

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Provascular GmbH: lead

Study Sites (3)

Herz-Zentrum Bad Krozingen Abteilung Angiologie

Bad Krozingen, 79189, Germany

Location

Jüdisches Krankenhaus Berlin, Gefäßzentrum

Berlin, 13347, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, 04289, Germany

Location

Study Officials

• Dierk Scheinert, Professor

  Park-Krankenhaus Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: November 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

DE (3)