What was the sample size and lesion count in the OAS Small Feasibility Trial at TCT 2005?

What was the sample size and lesion count in the OAS Small Feasibility Trial at TCT 2005?

• A. n=24 pts, 17 lesions
• B. n=17 pts, 24 lesions
• C. n=124 pts, 201 lesions
• D. n=150 pts, 100 lesions

Answer: (B)

In a small feasibility trial, the focus is on whether the approach can be applied safely in a limited group, with the number of patients and the total lesions treated or evaluated giving a sense of scale. The reported figures are 17 patients and 24 lesions, meaning 17 individuals were enrolled and a total of 24 lesions were addressed across them. This size is typical for feasibility work, where multiple lesions per patient are common, hence the lesion count can exceed the patient count. Larger numbers like 124 patients with 201 lesions or 150 patients with 100 lesions indicate a much bigger study, not a small feasibility trial.

In a small feasibility trial, the focus is on whether the approach can be applied safely in a limited group, with the number of patients and the total lesions treated or evaluated giving a sense of scale. The reported figures are 17 patients and 24 lesions, meaning 17 individuals were enrolled and a total of 24 lesions were addressed across them. This size is typical for feasibility work, where multiple lesions per patient are common, hence the lesion count can exceed the patient count. Larger numbers like 124 patients with 201 lesions or 150 patients with 100 lesions indicate a much bigger study, not a small feasibility trial.