Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system in Peripheral Superficial Femoral Arteries

Conditions
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Peripheral Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 to 95 years Male or non-pregnant female De novo lesions>70% or occlusions in the SFA (Superficial Femoral Artery) arteries suitable for stent angioplasty Max. 1 lesion within each leg should be treated as study lesions Lesions length range from ≥3 cm to ≤18 cm A patent inflow artery free from significant lesions (>50 % stenosis) as confirmed by angiography. Treatment of target lesion acceptable after successful treatment of inflow artery lesions. Reference vessel diameter ≥3 mm and ≤ 7 mm Successful guide wire passage of the lesion Symptomatic peripheral artery disease (Rutherford stage 2 to 5) Patient is willing to provide informed consent and comply with the required follow-up visits, testing schedule, and medication regimen Exclusion Criteria: Patients for whom an anti-platelet therapy, anticoagulants or thrombolytics are contraindicated Patients presenting a lasting intraluminal thrombosis at the lesion after a thrombolytic therapy Perforation at the location of the angioplasty characterized by secretion of the contrast medium Aneurysm of the artery to be treated All common contraindications for a PTA (Percutaneous Transluminal Angioplasty) Contraindications for stent angioplasty Hypersensitivity/allergy to nickel-titanium Hypersensitivity/allergy to any of the components of the delivery & dilation system Severe renal insufficiency (creatinine>2.0 mg/dL or glomerular filtration rate < 60 ml/min/1.73) Uncorrected bleeding disorder Major gastrointestinal bleeding within the last 6 months. Ipsilateral intervention other than target vessel Untreated ipsilateral iliac artery stenosis >70 % Previous stenting or prior surgery of the SFA In-stent restenosis Acute myocardial infarct within 72 h Less than one patent crural artery Popliteal stenosis > 70 % Manifest hyperthyroidism Acute onset of symptoms Leg-threatening ischemia Multimorbid patient with poor general condition Pregnant woman or becoming pregnant in < 2 yrs Living more than 100 km apart from the study center Patient actively participating in another investigational device or drug study History of hemorrhagic stroke within 3 months Previous or planned surgical or interventional procedure within 30 days of the procedure Acute or sub-acute thrombus in target vessel Acute vessel occlusion or sudden symptom onset Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| peripheral artery disease<br>de novo stenotic lesions in superficial femoral artery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization (TLR) | Target lesion revascularization (TLR) rate | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Adverse Event rate | 24 hours | 
| Adverse Event | Adverse Event rate | 48 hours | 
| Adverse Event | Adverse Event rate | 6 months | 
| Adverse Event | Adverse Event rate | 12 months | 
| Adverse Event | Adverse Event rate | 24 months | 
| Technical success | The ability to successfully complete stent angioplasty and achieve a residual diameter stenosis of ≤ 30 %. | 24 hours | 
| Procedural success | Procedural success rate | 24 hours | 
| Walking Impairment Questionnaire | Change from baseline in Walking Impairment Questionnaire scores | 6 months | 
| Walking Impairment Questionnaire | Change from baseline in Walking Impairment Questionnaire scores | 12 months | 
| Rutherford classification | Change from baseline in Rutherford stage | 48 hours | 
| Rutherford classification | Change from baseline in Rutherford stage | 6 months | 
| Rutherford classification | Change from baseline in Rutherford stage | 12 months | 
| Rutherford classification | Change from baseline in Rutherford stage | 24 months | 
| Health-related quality of life (SF-36 questionnaire) | Change from baseline in health-related quality of life (SF-36 questionnaire scores) | 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) | 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) | 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) | 24 months | 
| Ankle brachial index (ABI) | Change from baseline in Ankle brachial index (ABI) | 48 hours | 
| Ankle brachial index (ABI) | Change from baseline in Ankle brachial index (ABI) | 6 months | 
| Ankle brachial index (ABI) | Change from baseline in Ankle brachial index (ABI) | 12 months | 
| Ankle brachial index (ABI) | Change from baseline in Ankle brachial index (ABI) | 24 months |