Surgical Anti-reflux Venous Valve Endoprosthesis

Ongoing Pivotal Study to Evaluate VenoValve® for the Treatment of Chronic Venous Insufficiency

 

What is the SAVVE Study?

Chronic Venous Insufficiency (CVI) occurs when the valves inside the veins of your leg do not function properly, causing blood to flow backwards and pool in the lower leg, leading to elevated venous pressure inside the leg veins. The purpose of the SAVVE study is to determine whether the VenoValve® is a safe and effective treatment for patients with severe, deep venous CVI.

Prospective, Non-Blinded, Single Arm, Multi-Center Study

Primary
Safety Endpoint

30 DAYS

Primary
Efficacy Endpoint

6 MONTHS

What is the VenoValve Procedure?

The VenoValve is surgically implanted into a vein via a 5-to-6-inch incision under general or regional anesthesia. After the VenoValve procedure, the patient will stay in the hospital for one night for patient comfort.

Eligibility

Patients with severe CVI who experience symptoms including leg swelling, discoloration, heaviness, itchiness, pain, and open sores that are difficult to heal, may be candidates for the SAVVE study. Learn more at the study website.

 

Male and Female

Adult Patients

Chronic, axial deep
venous reflux secondary
to previous deep venous thrombosis or primary reflux

Failed at least 3 months of standard care including compression therapy, and in C6 patients, wound care

Creating Centers of Excellence Around Highly Populated Areas

Active Sites

Albany Medical Center
391 Myrtle Ave,
Albany, NY 12208
PI Name: Dr. Adriana Laser
Primary Contact: Brenda Romeo

Cedars-Sinai Medical Center
La Cienega Blvd.
Beverly Hills, CA 90211
PI Name: Dr. NavYash Gupta
Primary Contact: Goran Stankovic

Englewood Health
350 Engle St.
Englewood, NJ 07631
PI Name: Dr. Steven Elias
Primary Contact: Nathalia Clark

Henry Ford Health System
2799 West Grand Blvd.
Detroit, MI 48202
PI Name: Dr. Paul Corcoran
Primary Contact: Winnie Cheung

Indiana University
1801 North Senate Blvd., D3500
Indianapolis, IN 46202
PI Name: Dr. Raghu Motaganahalli
Primary Contact: Vickie Olsen

Jobst Vascular Institute /
Promedica Toledo Hospital

2109 Hughes Drive, CJT STE. 400
Toledo, OH 43606
PI Name: Dr. Gregory Kasper
Primary Contact: Christy Terrasi

Kaleidahealth/University at Buffalo
100 High St.
Buffalo, NY 14203
PI Name: Dr. Linda Harris
Primary Contact: Robin Stein

Miami Vascular Specialists
8950 N. Kendall Drive
Miami, FL 33176
PI Name: Dr. Michele Taubman
Primary Contact: Ivette Cruz

NYU Langone
530 1st Ave, HCC6F
New York, NY 10016
PI Name: Dr. Mikel Sadek
Primary Contact: Jacqueline Bott

Pima Heart and Vascular
2404 E River Road, Suite 100
Tucson, AZ 85718
PI Name: Dr. Scott S Berman
Primary Contact: Aleksander Herber (520) 576.4133

Saint Louis University
1008 S Spring Ave.
Saint Louis, MO 63110
PI Name: Dr. Matthew Smeds
Primary Contact: (314) 977.4730

Sentara
600 Gresham Drive
Norfolk, VA 23507
PI Name: Dr. David Dexter
Primary Contact: Sarah Havert

Stony Brook Medicine
101 Nicolls Rd.
Stony Brook, NY 11794
PI Name: Dr. Antonios Gasparis
Primary Contact: Andrew Bryan

TriHealth
375 Dixmyth Avenue
Cincinnati, OH 45220
PI Name: Dr. Patrick Muck
Primary Contact: Faizan Qureshi

University of Alabama at Birmingham
Vascular Surgery and Endovascular Therapy
BDB 652, 1808 7th Ave. South
Birmingham, AL 35294
PI Name: Dr. Marc Passman
Primary Contact: Rebecca St. John

University of Chicago
5841 S. Maryland Ave., MC 5028
Chicago, IL 60637
PI Name: Dr. Chelsea Dorsey
Primary Contact: MacKenton Johnson

University Hospitals Cleveland
Medical Center
11100 Euclid Ave.
Cleveland, OH 44106
PI Name: Dr. Karem Harth
Primary Contact: Emily Mullenax

University of North Carolina
3024 Burnett-Womack Bldg
Chapel Hill, NC 27516
PI Name: Dr. William Marston
Primary Contact: Zachary Gortler

UPMC
5200 Centre Avenue
Pittsburgh, PA 15232
PI Name: Dr. Rabih Chaer
Primary Contact: Julianna Sheline

University of Utah
30 N. 1900 East, Room 3C344 SOM
Salt Lake City, UT 84132
PI Name: Dr. Claire L. Griffin
Primary Contact: Maria Maloney

Vanderbilt University Medical Center
D-5237 Med Center North,
1161 21st Ave. South
Nashville, TN 37232
PI Name: Dr. Mark Iafrati
Primary Contact: Celia Nunez

Yale New Haven Hospital
330 Cedar St, Boardman 204
New Haven, CT 06510
PI Name: Dr. Cassius Iyad Ochoa Chaar
Primary Contact: Patrice Lauture

Future Sites

Coastal Vascular Institute
7720 US 98 West, Suite 240
Destin, Florida 32550
PI Name: Geoffrey Risley
Primary Contact: Kelly Stewart

Houston Methodist Hospital
6550 Fannin St.
Houston, TX 77030
PI Name: Dr. Eric Peden
Primary Contact: Kim Donlon, RN

Active Sites    Future Sites

If you are interested in participating in the ongoing SAVVE study, please contact your physician or register for more information at the study website.

 

 

Chronic Venous Insufficiency

VenoValve®

Publications