Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01937351
Brief Summary:
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.
Detailed Description:
The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be evaluated using technical success, defined as the percent of target lesions that have a residual diameter stenosis \<50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.
Study:
NCT01937351
Study Brief:
Protocol Section:
NCT01937351