Here is the design of a clinical trial:

Official Title: Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty

Included conditions:
- Peripheral Arterial Disease

Study Armgroups:
- {'label': 'Sirolimus-coated group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: sirolimus-coated balloon catheter']}
- {'label': 'Uncoated group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: uncoated balloon catheter']}

Interventions:
- {'type': 'DEVICE', 'name': 'sirolimus-coated balloon catheter', 'description': 'angioplasty with sirolimus-coated balloon catheter', 'armGroupLabels': ['Sirolimus-coated group']}
- {'type': 'DEVICE', 'name': 'uncoated balloon catheter', 'description': 'angioplasty with uncoated balloon catheter', 'armGroupLabels': ['Uncoated group']}

Primary Outcomes:
- {'measure': 'unplanned major amputation of the target limb', 'description': 'An unplanned major amputation is defined as any amputation above the ankle on the target limb, which was not planned or not expectable at the time of screening or randomization. Patients with scheduled amputation undergoing re-vascularization to improve wound healing are referred to as planned amputation and will not count for the primary outcome', 'timeFrame': 'one year'}
- {'measure': 'endovascular or surgical target lesion re-vascularization for critical limb ischemia', 'description': 'Critical limb ischemia is defined according to a Fontaine stage (classes III-IV)', 'timeFrame': 'one year'}

Please estimate the sample size based on the assumption: 
A power of 80% and a type I error rate of α = 2.5% one-sided. Assuming a drop-out rate of 5%, including randomization failures.
Sample size {14}
        The sample size calculation is based on previous studies reporting MALE rates in PAD patients after re-vascularization procedures. These studies were heterogeneous in study design, patient selection, techniques (proportion of patients with endovascular approach), and findings [13â24]. Hess et al. reported a MALE incidence of 10% at 12âmonths among 381,415 re-vascularized patients that were included in the Premier Healthcare Database between April 2009 and September 2014 [19]. In addition, there were two larger interventional studies reporting 30-day MALE incidence after surgical or endovascular therapy of symptomatic PAD patients. Fashandi et al. reported a MALE incidence of 3.2% in patients with claudication at 1âmonth following therapy [21]. Mehaffey et al. reported a MALE incidence of 12.2% in patients with critical limb ischemia (CLI) [22]. The COMPASS trial estimated a MALE incidence of 2.0% among 6.341 patients with PAD at 21âmonths, of which 35% were asymptomatic. The MALE incidence was 3.6% among the subgroup of patients with previous re-vascularization procedures [24]. A subgroup analysis of the Fourier trial estimated a MALE incidence of 1.5% among 3.642 patients with PAD (31% asymptomatic) at 12âmonths [23]. In the XTOSI study, the 6-month amputation-free survival was 90% in patients receiving sirolimus-coated balloon catheters.
        Based on these studies, assuming a 10% event rate (MALE) within 12âmonths in both the control and intervention group, and a non-inferiority margin of 5% expressed as absolute risk difference, a total of 1132 patients (566 patients per treatment group) allow to show non-inferiority of the intervention group with a power of 80% and a type I error rate of Î± = 2.5% one-sided. Assuming a drop-out rate of 5%, including randomization failures, a total of 1200 patients will be randomized in the study.