A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

October 18, 2022

Primary Completion Date

May 15, 2024

Study Completion Date

May 23, 2025

Conditions
Peripheral Arterial DiseaseCritical Limb Ischemia
Interventions
DEVICE

Bare Temporary Spur Stent System

Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.

Trial Locations (48)

10032

Columbia University Irving Medical Center, New York

19010

Lankenau Institute for Medical Research, Bryn Mawr

19107

Pennsylvania Hospital, Philadelphia

23507

Sentara Norfolk General, Norfolk

28906

Sunrise Vascular, Murphy

29425

Medical University of South Carolina (MUSC), Charleston

29605

Prisma Health, Greenville

32003

First Coast Cardiovascular Institute, Fleming Island

32177

Ansaarie Cardiac & Endovascular Center of Excellence, Palatka

32503

Coastal Vascular and Interventional Center, Pensacola

32792

Guardian Research, Winter Park

33176

Baptist Hospital of Miami, Miami

33436

Palm Beach Heart and Vascular, Boynton Beach

33484

Delray Medical Center, Delray Beach

34205

Bradenton Cardiology, Bradenton

34471

Surgical Specialists of Ocala, Ocala

37232

Novant Health Heart & Vascular Institute, Matthews

Vanderbilt University Medical Center, Nashville

43214

Ohio Health, Columbus

44195

Cleveland Clinic, Cleveland

46321

Community Healthcare Systems, Munster

48066

Eastlake Cardiovascular PC, Roseville

49048

Advanced Vascular Surgery, Kalamazoo

49525

Advanced Cardiac and Vascular Centers for Amputation Prevention, Grand Rapids

52722

UnityPoint Health Trinity Bettendorf Hospital, Bettendorf

60540

Midwest Cardiovascular Institute, Naperville

60612

Rush University, Chicago

63128

Mercy South, St Louis

65211

University of Missouri, Columbia

70121

Ochsner Health, New Orleans

70506

Cardiovascular Institute of the South, Lafayette

70809

Baton Rouge General Medical Center, Baton Rouge

72211

Arkansas Heart Hospital, Little Rock

72401

St. Bernards Heart and Vascular, Jonesboro

75390

UT Southwestern Medical Center, Dallas

78404

Texas Cardiac and Vascular Institute, Corpus Christi

79430

Texas Tech University Health Sciences Center, Odessa

79902

El Paso Cardiology Associates, El Paso

80045

Rocky Mountain Regional VA Medical Center, Aurora

92868

University of California, Irvine Health, Orange

Vascular & Interventional Specialist of Orange County, Orange

06820

Vascular Care Connecticut (site) / Vascular Breakthroughs (research support), Darien

06484

Southern CT Vascular Center, Shelton

02114

Massachusetts General Hospital, Somerville

02482

Vascular Care Group (site) / Vascular Breakthroughs (research support), Wellesley

08822

Advanced Heart and Vascular Institute of Hunterdon, Flemington

07666

Holy Name Medical Center, Teaneck

02906

The Miriam Hospital, Providence

All Listed Sponsors
lead

ReFlow Medical, Inc.

INDUSTRY