Here is the design of a clinical trial:

Official Title: Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery

Included conditions:
- Peripheral Artery Disease

Study Armgroups:
- {'label': 'Sirolomus DCB group', 'type': 'EXPERIMENTAL', 'description': 'Intervention with Sirolimus-coated balloon catheter', 'interventionNames': ['Combination Product: Percutaneous Transluminal Angioplasty (PTA)']}
- {'label': 'Paclitaxel DCB group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention with Paclitaxel-coated balloon catheter', 'interventionNames': ['Combination Product: Percutaneous Transluminal Angioplasty (PTA)']}

Interventions:
- {'type': 'COMBINATION_PRODUCT', 'name': 'Percutaneous Transluminal Angioplasty (PTA)', 'description': 'PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery', 'armGroupLabels': ['Paclitaxel DCB group', 'Sirolomus DCB group']}

Primary Outcomes:
- {'measure': 'Patency rate (Absence of clinically driven target lesion revascularization)', 'description': 'patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of ≥ 20% or \\> 0.15 when compared to post-procedure or restenosis with PVR \\> 2.4 evaluated by duplex ultrasound', 'timeFrame': 'one year after study procedure (PTA with medical product under investigation or comparator)'}
- {'measure': 'Safety outcome', 'description': 'Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion', 'timeFrame': 'through 12 months post-procedure'}

Please estimate the sample size based on the assumption: 
Power of 89% for each test and 80% for both primary outcomes. One-sided Farrington-Manning test will be applied. A dropout rate of 10% is assumed.
Sample size {14}
        In the randomized controlled pilot COMPARE trial, 1-year primary patency after paclitaxel-coated balloon angioplasty (IN.PACT DCB) was 89.0% [14]. In addition, the IN.PACT global study revealed 94% freedom from the primary composite safety endpoint in the long-lesion imaging cohort [15].
        From this, we calculated that 430 participants (215 in each group) need to be analysed regarding the primary efficacy outcome, and 280 (140 in each group) regarding the primary safety outcome to show noninferiority of the Magic Touch sirolimus DCB over paclitaxel-coated balloon angioplasty with a power of 89% for every single test and of 80% for both primary outcomes. Noninferiority margin is set at 10% for both outcomes.
        As heterogeneity regarding 12-month primary patency and need for TLR (the main driver of the primary composite safety endpoint in terms of quantity) is substantial even across different types of paclitaxel-coated balloons (65 to 86% [I2 = 54%] and 71 to 93% [I2 = 66%], respectively [16]); a deviation from the average by 10% with sirolimus-coated balloon angioplasty would still be within the range that can be considered noninferior.
        One-sided Farrington-Manning test will be applied for the primary outcomes. Finally, assuming a dropout rate of 10%, 478 patients (239 per group) should be recruited.