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Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents — BIOFLEX-I  

Peripheral Artery Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01319812
Study type Interventional
Source Biotronik, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2011
Completion date September 7, 2017
View Details
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