Here is the design of a clinical trial:

Official Title: A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.

Included conditions:
- Peripheral Arterial Disease

Study Armgroups:

Interventions:

Primary Outcomes:
- {'measure': 'Freedom from clinically-driven TLR', 'description': 'CD-TLR was deﬁned as any reintervention within the target lesion(s) because of recurrent symptoms. Freedom form CD-TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.', 'timeFrame': '24 months'}

Please estimate the sample size based on the assumption: 
A 10% lost to follow-up rate is assumed. Statistical significance is considered at a two-sided p<0.05. Normal distribution and homogeneous tests of variance will be performed. Continuous data will be presented as mean±SD, and categorical data as numbers and percentages. Various statistical tests will be used based on data distribution and variance homogeneity.
Sample size and statistical analysis
        Taking into account a 10% lost to follow-up rate and a target enrolment of 300 patients, 270 patients will be included in the effectiveness analysis.
        Statistical analysis will be performed using Stata SE V.15.1 software (StataCorp). Continuous data will be presented as the meanÂ±SD, and categorical data will be presented as numbers (n) and percentages (%). Normal distribution and homogeneous tests of variance will be performed in advance. For the data groups that have a normal distribution and homogeneous variances, comparisons between two groups will be made using unpaired Studentâs t-tests and one-way analysis of variance, followed by Bonferroni tests for multiple group comparisons. For the data groups that do not have a normal distribution or homogeneous variances, nonparametric tests will be used. Univariate and multivariate analyses will be performed by logistic analysis. Generally, a two-sided p<0.05âwill be considered statistically significant unless otherwise stated.