Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty. The CE-approved device will be used according to its intended use. Beyond the standard of care no further interventions are scheduled. Therefore, this trial is subject to the exception to the rule §23b of the German Medical Device Act (MPG), which includes the national implementation of EC directive 93/42/EEC.
The aim of this non-randomized post-market clinical follow-up study is to confirm long-term safety and effectiveness of the CE-approved Camouflage-coated self expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in superficial femoral artery in 120 compliant patients suitable for stent angioplasty. The primary end point is the target lesion revascularization after 12 months. Further follow-ups are scheduled at discharge, 30 days, 6 and 24 months.
Study Type
OBSERVATIONAL
Enrollment
120
Uniklinikum Freiburg, Abteilung Röntgendiagnostik
Freiburg im Breisgau, Baden-Wurttemberg, Germany
RECRUITINGUniklinikum Gießen und Marburg, Diagnostische und Interventionelle Radiologie
Marburg, Hesse, Germany
RECRUITINGAugusta-Krankenhaus, Klinik für Gefäßchrirugie
Düsseldorf, North Rhine-Westphalia, Germany
RECRUITINGHeinrich Braun Klinikum Zwickau, Radiologie und Neuroradiologie
Zwickau, Saxony, Germany
RECRUITINGCCP - Istituto di Cura "Città di Pavia"
Pavia, Lombardy, Italy
RECRUITINGTarget lesion revascularization (TLR)
Target lesion revascularization (TLR) rate
Time frame: 12 months
Adverse Event
Adverse Event rate
Time frame: 24 hours
Adverse Event
Adverse Event rate
Time frame: 48 hours
Adverse Event
Adverse Event rate
Time frame: 6 months
Adverse Event
Adverse Event rate
Time frame: 12 months
Adverse Event
Adverse Event rate
Time frame: 24 months
Technical success
The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %.
Time frame: 24 hours
Procedural success
Procedural success rate
Time frame: 24 hours
Walking Impairment Questionnaire
Change from baseline in Walking Impairment Questionnaire scores
Time frame: 6 months
Walking Impairment Questionnaire
Change from baseline in Walking Impairment Questionnaire scores
Time frame: 12 months
Rutherford classification
Change from baseline in Rutherford stage
Time frame: 48 hours
Rutherford classification
Change from baseline in Rutherford stage
Time frame: 6 months
Rutherford classification
Change from baseline in Rutherford stage
Time frame: 12 months
Rutherford classification
Change from baseline in Rutherford stage
Time frame: 24 months
Health-related quality of life (SF-36 questionnaire)
Change from baseline in health-related quality of life (SF-36 questionnaire scores)
Time frame: 12 months
Primary patency
Percentage of lesions that reach endpoint without TLR or with stenosis \< 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) \< 2.4)
Time frame: 6 months
Primary patency
Percentage of lesions that reach endpoint without TLR or with stenosis \< 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) \< 2.4)
Time frame: 12 months
Primary patency
Percentage of lesions that reach endpoint without TLR or with stenosis \< 50% on duplex ultrasonography (PSVR (Peak Systolic Velocity Ratio) \< 2.4)
Time frame: 24 months
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Time frame: 48 hours
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Time frame: 6 months
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Time frame: 12 months
Ankle brachial index (ABI)
Change from baseline in Ankle brachial index (ABI)
Time frame: 24 months
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