Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system (RECAM)

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.)