Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions (TINTIN)

This is an interventional treatment trial for Peripheral Arterial Disease Read More

General inclusion criteria:

• Patient presenting a score from 2 to 5 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life expectancy of at least 12 months
• Prior to enrolment, the guidewire has crossed target lesion
• Patient is eligible for treatment with the Luminor Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter and the iVolution stent
• Male, infertile female or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic inclusion criteria

• De novo and post-percutaneous transluminal angioplasty (PTA) restenotic lesions located in the femoropopliteal arteries suitable for endovascular therapy
• The target lesion is located within the native femoropopliteal artery
• The length of the target lesion is ≥ 150mm and considered as TASC C or D lesion according to the TASC II classification.
• The target lesion has angiographic evidence of stenosis > 50% or occlusion which can be passed with standard guidewire manipulation
• Target vessel diameter visually estimated is >4mm and <6.5 mm
• There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention

Exclusion Criteria:

• Patient refusing treatment
• Presence of a stent in the target lesion that was placed during a previous procedure
• Untreated flow-limiting inflow lesions
• Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
• Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Patients with uncorrected bleeding disorders
• Aneurysm located at the level of the superficial femoral artery/popliteal artery
• Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Severe medical comorbidities (severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Use of thrombectomy, atherectomy or laser devices during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure