Outcome Post Endovascular Brachytherapy for Neointimal Hyperplasia – Rhenium-188

Not Applicable

Recruiting

Conditions: I70.2
Atherosclerosis of arteries of extremities

Registration Number: DRKS00000592

Lead Sponsor: itm FlowMedical GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of restenosis for target lesion after 12 months as indicated by imaging (colour-coded duplex sonography, CDS)

Secondary Outcome Measures

Name	Time	Method
After 12 months: Rate of reintervention / revascularisation for target lesion (TLR / TVR), change in Ankle Brachial Index (ABI), change in Rutherford category, rate of complications, Adverse Events (AE, SAE) after treatment and during the follow-up period, Major Adverse Events, overall survival, survival without amputation, health-related quality of life.