NCT03192696

Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries

INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Avinger, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.

Detailed description

This is a prospective, global, single-arm, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy of in-stent restenotic (ISR) lesions in lower extremity arteries. The trial will enroll up to 140 subjects diagnosed with peripheral arterial disease of the lower extremities that have previously been treated with stenting at up to 20 sites. The primary disease must be located in reference vessel diameter of \>3.0mm and ≤7.0mm. Trial success is focused on safety, including rates of major adverse events through 30 days as adjudicated by a Clinical Events Committee, and effectiveness, which will be evaluated using technical success defined as the percent of target lesions that have 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	Atherectomy Catheter	Treatment of restenotic lesions within stents previously placed within the artery.

Timeline

• Start date: 2017-10-19
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2017-06-20
• Last updated: 2023-03-28

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study