Here is the design of a clinical trial:

Official Title: Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions A Prospective, Multi-centre, Randomised Study

Included conditions:
- Peripheral Artery Disease
- Artery Stenosis

Study Armgroups:
- {'label': 'Endovascular procedure', 'type': 'ACTIVE_COMPARATOR', 'description': 'Common femoral artery (target lesion) to be treated with directional atherectomy and paclitaxel-coated balloon angioplasty. Optional: stentimplantation.', 'interventionNames': ['Device: Atherectomy and paclitaxel-coated balloon angioplasty']}
- {'label': 'Surgery', 'type': 'ACTIVE_COMPARATOR', 'description': 'Common femoral artery (target lesion) to be treated with open, surgical endarterectomy', 'interventionNames': ['Procedure: Open, surgical endarterectomy']}

Interventions:
- {'type': 'DEVICE', 'name': 'Atherectomy and paclitaxel-coated balloon angioplasty', 'description': 'Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery', 'armGroupLabels': ['Endovascular procedure']}
- {'type': 'PROCEDURE', 'name': 'Open, surgical endarterectomy', 'description': 'open, surgical endarterectomy of the common femoral artery', 'armGroupLabels': ['Surgery']}

Primary Outcomes:
- {'measure': 'Primary patency', 'description': 'Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio \\>2.4.', 'timeFrame': '12 month'}

Please estimate the sample size based on the assumption: 
Significance level (alpha) = 0.05 (one-sided), power (beta) = 0.2, proportion = 0.8, margin = -0.2, and a lost-to-follow-up rate of 15%.
Sample size {14}
        Based on the available data the primary patency rate at 12Â months after successful endovascular therapy with directional atherectomy and DCB is estimated at 80% [2]. Assuming a comparable primary patency of 90% after open surgery [alphaâ=â0.05 (one-sided) and betaâ=â0.2, proportionâ=â0.8, marginâ=ââââ0.2], 260 patients must be included in this trial to reveal the non-inferiority of the treatment groups. Considering a lost-to-follow-up rate of 15%, 306 patients (153 patients in each group) have to be enrolled. Initial estimated enrollment time was 2Â years but had to be extended due to the COVID-19 pandemic.