NCT01319812

Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents

The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

Conditions

• Peripheral Artery Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Astron Stents	Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.
DEVICE	Pulsar Stents	Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-09-01
• Completion: 2017-09-07
• First posted: 2011-03-22
• Last updated: 2019-03-21
• Results posted: 2017-06-05

Locations

35 sites across 2 countries: United States, Canada