At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 463 enrolled

Drug / intervention

Astron Stents +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01319812

NCT01319812Phase 2Completed

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

Biotronik, Inc.·interventional·Posted Mar 22, 2011·Updated Mar 21, 2019

In Brief

A Phase 2 clinical trial evaluating Astron Stents and Pulsar Stents for Peripheral Artery Disease and Peripheral Vascular Disease. Completed, enrolled 463 participants across 35 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPeripheral Artery Disease, Peripheral Vascular Disease

CountriesCanada, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedMar 2011

Enrollment StartJul 2011

Primary CompletionSep 2015

Study CompletionSep 2017

TodayJul 2026

First PostedMar 22, 2011

Enrollment StartJul 1, 2011

Primary CompletionSep 1, 2015

Study CompletionSep 7, 2017

TodayJul 2, 2026

Enrollment to primary: 4.2 yearsPosted 15.3 years ago

Interventions

Astron Stentsdevice

Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.

Pulsar Stentsdevice

Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.