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

PHASE2CompletedINTERVENTIONAL
Enrollment

463

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

September 30, 2015

Study Completion Date

September 7, 2017

Conditions
Peripheral Artery DiseasePeripheral Vascular Disease
Interventions
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.

Trial Locations (35)

10065

New York

10467

The Bronx

15232

Pittsburgh

17011

Camp Hill

18901

Doylestown

19047

Langhorne

20010

Washington D.C.

27262

High Point

28054

Gastonia

29605

Greenville

29732

Rock Hill

37660

Kingsport

38801

Tupelo

43606

Toledo

43614

Toledo

45267

Cincinnati

46321

Munster

48197

Ypsilanti

48601

Saginaw

48912

Lansing

49519

Wyoming

61107

Rockford

64114

Kansas City

70360

Houma

75069

McKinney

75701

Tyler

76712

Waco

78745

Austin

79106

Amarillo

94538

Fremont

06510

New Haven

07450

Ridgewood

02906

Providence

Unknown

Montreal

Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik, Inc.

INDUSTRY