Occluded or stenotic superficial femoral and/or popliteal arteries Circulatory System Arterial embolism and thrombosis
Conditions
Interventions
Observational collection of routine hospital practice, clinical/telephone follow-up and monitoring of all serious adverse events* and medication regiments.
*An adverse event is considered serious i
Sponsors
Terumo Europe N.V. (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must fulfil all of the following criteria: 1. Patients with symptomatic one or two legs ischaemia, requiring treatment of superficial femoral artery (SFA) or popliteal artery (two or more by Rutherford classification) 2. Single lesions per leg with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion, which can be covered by maximum two stents 3. Target vessel reference diameter greater than or equal to 4 mm and less than or equal to 6 mm (by visual estimate) 4. Target lesion length should consider that maximum two Misago® stents can be implanted per lesion with recommended overlap of 2 mm 5. At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography 6. Patient is suitable candidate for femoral-popliteal artery bypass surgery 7. Aged 18 years or older, either sex
Exclusion criteria
Exclusion criteria: Patients with any of the following should be excluded: 1. Pregnancy 2. Previous bypass surgery or stenting in the target vessel 3. Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure 4. Co-existing aneurismal disease of the abdominal aorta, iliac or popliteal arteries 5. Acute thrombophlebitis or deep venous thrombosis 6. Haemodynamic instability 7. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion) 8. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy 9. Known intolerance to study medications, contrast agents or nitinol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of clinically driven target lesion revascularisation at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success defined as a successful access and deployment of the device with recanalisation determined by less than 30% residual stenosis by angiography at the baseline procedure 2. Clinical success defined as technical success without the occurrence of serious adverse events during procedure 3. Ankle-Brachial Index (ABI) improvement of greater than or equal to 0.1 (ABI before procedure compared with ABI at discharge and at 6 and 12 months) 4. Primary and secondary patency rate (if duplex ultrasound available) defined as less than 50% diameter reduction and peak systolic velocity less than 2.4 5. Improvement of walking distance at discharge and at 6 and 12 months compared with walking distance before procedure (if treadmill test available) 6. Clinically driven target vessel revascularisation at 6 and 12 months 7. Major complications at 6 and 12 months, including amputation of the distal part of the foot, the leg below the knee and the thigh 8. Vascular complications 9. Bleeding complications 10. The Rutherford classification of chronic limb ischaemia at discharge and at 6 and 12 months post-procedure 11. Stent fracture at 6 and 12 months post-procedure | — |
Countries
Austria, Belarus, Belgium, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed