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: Denice Dubuclet
Coastal Vascular and Interventional
7720 US 98 West, Suite 240
Destin, FL 32550
PI Name: Dr. Geoffrey Risley
Primary Contact: Michele Schindler
Henry Ford Health System
2799 West Grand Blvd.
Detroit, MI 48202
PI Name: Dr. Paul Corcoran
Primary Contact: Romy Ancog
Houston Methodist Hospital
6550 Fannin St.
Houston, TX 77030
PI Name: Dr. Eric Peden
Primary Contact: Kikelomo Akindoju
Indiana University
1801 North Senate Blvd., D3500
Indianapolis, IN 46202
PI Name: Dr. Raghu Motaganahalli
Primary Contact: Janet Klein
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: Keivy Garcia
NYU Langone
530 1st Ave, HCC6F
New York, NY 10016
PI Name: Dr. Mikel Sadek
Primary Contact: Gina Bernardez
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 Have
TriHealth
375 Dixmyth Avenue
Cincinnati, OH 45220
PI Name: Dr. Patrick Muck
Primary Contact: Melody Vespie
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
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: Julie Hales
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: Edgar Benitez
Active 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
Publications
The VenoValve® and enVVe™ are investigational medical devices currently in development. Neither device is approved or cleared for any indication in any market. The VenoValve® is only available for use in the United States in pre-market clinical studies.