Minimal invasive balloon expansion versus bypass operation to treat complicated occlusions and stenoses of the femoral and popliteal arteries

Not Applicable

Completed

Conditions: Atherosclerosis
Circulatory System
Peripheral arterial occlusive disease of the lower extremity

Registration Number: ISRCTN18315574

Lead Sponsor: Paracelsus Medical University (PMU)

Brief Summary: 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31786218/ 2-year results (added 12/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35185122/ 4-year results (added 12/08/2022) 2023 Results article in https://doi.org/10.3390/jcm12103507 Long-Term Outcome of Bypass Surgery versus Endovascular Revascularization in Long Femoropopliteal Lesions (added 10/05/2024) 2022 Results article in https://doi.org/10.3390/medicina58091225 Long-Term Results of Endovascular Treatment with Nitinol Stents for Femoropopliteal TASC II C and D Lesions (added 10/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 218

Inclusion Criteria

1. Aged 30 years and over
2. Peripheral arterial occlusive disease of the lower extremity due to atherosclerosis
3. Disabling claudication (walking distance < 200 m) or critical ischemia (rest pain and/or tissue loss)
4. Radiologically verified long lesions (TASC II Type C or D) of the femoral and/or politeal artery
5. Symptoms for more than 2 months
6. Unimpaired ipsilateral iliac arteries
7. Capacity to provide informed consent

Exclusion Criteria

1. Acute ischemia
2. Embolic occlusion of the femoropopliteal segment
3. Trauma
4. Non-disabling claudication (walking distance > 200 m)
5. Radiologically verified short femoropopliteal lesions (TASC II Type A and B)
6. Vasculitis
7. Renal insufficiency (glomerular filtration rate < 45 ml/min/1.73 m2)
8. No informed consent
9. Pregnancy
10. Patient too frail for bypass surgery: American Society of Anesthesiologists (ASA) - Class >3