NCT01937351

Evaluation of the Pantheris Atherectomy System

Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Avinger, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Pantheris System	Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

Timeline

• Start date: 2013-06-25
• Primary completion: 2015-07-15
• Completion: 2015-09-20
• First posted: 2013-09-09
• Last updated: 2021-03-25
• Results posted: 2017-05-12

Locations

21 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study