Outcome Post Endovascular Brachytherapy for Neointimal Hyperplasia – Rhenium-188 - OPEN-188

itm FlowMedical GmbH0 个研究点目标入组 140 人开始时间: 2011年5月23日最近更新: 2024年8月19日

适应症

试验速览

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•Patient is male or female and aged 55 years or over.
•Patient is legally competent.
•Patient declares his/ her agreement to participate in follow-up examinations after 6 and 12 months.
•After explanation of the clinical trial, patient has given his/ her written consent to take part.
•Patient has symptomatic peripheral vascular disease (Rutherford category 2 to 6)
•Patient has repeat stenosis after PTA or in-stent restenosis (interval since previous intervention is least 6 weeks)
•Patient has an arterial femoropopliteal lesion which can be treated by means of percutaneous intervention.
•Patient has a haemodynamically relevant lesion (degree of stenosis >50%)
•The length of the lesion to be treated is between 1 and 13 cm.
•In this patient it is possible that, after the intervention, at least 1 distal runoff vessel will be present in the lower leg.

•Limited walking capacity, pain or symptoms not caused mainly by arterial occlusive disease
•Acute ischaemia of the extremities
•Existing supra- and periinguinal stenoses/ occlusions that are haemodynamically relevant and cannot be treated with any other intervention or surgery
•Already included in OPEN-188 with another target lesion
•Serious underlying illness making 12 months’ follow-up unlikely
•Contraindication for, or allergy to, prolonged medication with thrombocyte aggregation inhibitors (e.g. ASA, clopidogrel) or anticoagulants which may be necessary in the course of the intervention
•Brachytherapy has already been carried out on the study leg” and the lesions cannot be distinguished from each other with certainty (<= 5 cm apart).
•Renal insufficiency with kidney function limitation of more than 50% (GFR <45 ml/min/1.73 m2)
•Untreatable latent or manifest hyperthyreosis
•Disturbance of blood clotting (Quick value <50%, thrombocytes < 50x103)
•Simultaneous participation in another clinical trial which could interact with this one in regard to blood vessel region, aims or accompanying medication.

发起方

itm FlowMedical GmbH