I70.2
Conditions
Interventions
Group 1: intravascular radiotherapy with Rhenium-188 after PTA (itm Rhenium-PTA)
Group 2: prolonged PTA without active Rhenium (Placebo-PTA)
Sponsors
itm FlowMedical GmbH
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of restenosis for target lesion after 12 months as indicated by imaging (colour-coded duplex sonography, CDS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactUte Golbach
IGSF GmbH
Outcome results
None listed