Below-the-knee Obstruction, Femoropopliteal Occlusive Disease, Iliac Artery Disease, Peripheral Arterial Disease
Conditions
Brief summary
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
Interventions
DEVICEstent or balloon
Endovascular treatment with stent or balloon according to current practice
Sponsors
be Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must sign the informed consent form prior to the index-procedure. 2. Patient is older than 18 years. 3. Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime. 4. Patient suffers from intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5). 5. Target lesion is an occlusion or diameter stenosis is ≥70% by visual estimate. 6. Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery) .
Exclusion criteria
1. Patients with Rutherford 0, 1 and 6. 2. Patient is pregnant. 3. Patients with serum creatinine \>2.0 mg/dL or renal dialysis. 4. Patient has an acute thrombus or aneurysm in the target arteries. 5. Patient has a life expectancy of \<12 months. 6. Patient with bypass that involves the target arteries. 7. Patient has a target lesion that cannot be crossed with a guidewire. 8. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability. 9. Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted. 10. Contraindication for anti-thrombotic therapy (coagulopathy, …). 11. Patient has a known intolerance to anti-thrombotic medication or contrast agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binary restenosis | at 12 months follow-up | Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate procedural outcome | up to 12 months follow-up | The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of \<30% of the treated target lesion on the procedural completion angiography. and procedural success defined as a combination of technical success and absence of procedural complications. |
| Clinical outcome | at baseline | Rutherford classification |
| Primary sustained clinical improvement | at 12 months follow-up | defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients. |
| Secondary sustained clinical improvement | at 12 months follow-up | defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients. |
| Device-related complications | up to 12 months follow-up | Registration of peri- and early/late postoperative complications |
| Mortality | up to 12 months follow-up | Procedure-related and all-cause mortality. |
| Amputation | up to 12 months follow-up | minor amputation defined as below the ankle and major defined as above the ankle. |
| Stent fracture | up to 12 months follow-up | Only if restenosis occurs, stent fracture will be examined (when Optimed Sinus Superflex 635 stent is used). |
| Target lesion revascularization (TLR) | up to 12 months follow-up | defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena). |
Countries
Belgium
Outcome results
None listed