Clinical Research
Critical Limb Ischemia
Treatment of Lower Extremity Critical Limb Ischemia via Modulation of VEGF-A using and Engineered Zinc-Finger Transcription Factor to Evaluate
Safety and the Effects on Progenitor Cells
Subjects with CLI receive 10 injections of EW-A-401 in the index leg on Day 0 and again on Day 5. (An optional additional dosing between Day 30
and 90 is currently going to the IRB as an amendment.) Clinic follow up lasts one year and phone follow up lasts 15 years.
Intermittent Claudication
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Dose Selection Study of Ad2/Hypoxia Inducible Factor (HIF)
- 1a/VP16 in Patients with Intermittent Claudication
Subjects with intermittent claudication receive 20 injections in each leg on Day 0. Follow up clinic visits last 3 years and phone follw up lasts 15
years.
Current Aneurysm and Carotid Trials
TX2 - Patients undergoing TAA Repair - Sponsored by Cook
TAG - Patients undergoing TAA Repair - Sponsored by W.L. Gore
OVER - Open vs. Endovascular Repair of AAA - Veterans Administration Cooperative Study
Patients undergoing AAA reapir, must be OPEN and ENDO candidates (VA patients only)
CP-04-002 - Clinical study to evaluate the use of the Endologix Powerlink Suprarenal Proximal Cuff - Sponsored by Endologix
PIVOTAL - Positive Impact of EndoVascular Options for Treating Aneurysms Early - Sponsored by Medtronic and Cleveland Clinic Foundation
Patients with AAA's 4-5 cm, willing to be randomized to surveillence or early endovascular repair with Medtronic Aneuryx
CREST - Carotid Revascularization ENdarterectomy vx. Stent Trial - NIH/Guidant UMDNJ/UAB
Patients requireing carotid revascularization willing to be randomized to open or stenting.
Current Claudication Trials
Skeletal Muscle Predictors in Bypass Graft Failure
Must have CLI with planned surgical revascularization procedure of the popliteal artery
AMNESTI Study objective is to understand the benefits and mechanisms of exercise training in subject with PAD
Must have calf/thigh/buttock pain or crampinig with exercise that is relieved with rest, a resting ABI <0.90 in at least one leg. Randomized to either
home or a supervised exercise.
AV Access Trials
Atrium Clearway Transcatheter Balloon Irrigation Study - Sponsored by Atrium Medical
Thrombosed PTFE undergoing fistulolysis
Phase II, Open Label, Ascending Dose Study of the Safety of Trinam (EG004) in Stenosis Prevention at the Graft-Vein Anastamosis Site in Dialysis
Patients - Sponsored by Ark Therapeutics
Must be receiving upper extermity PTFE graft and agree to pre-surgical malignancy screening and rigorous follow up
Safety of Vascugel Treatment after the Creation of Arteriovenous Access for Hemodialysis Use - IRB approval pending - Sponsored by Pervasis,
Inc.
Must be the first AVF in upper extremity or an AVG with one prior failed AVF
GRAFTcath Vascular Access System (GVAS) Clinical Study Protocol - Sponsored by GRAFTcath, Inc.
Upper right arm site needed for GVAS device implant (Control patients can receive graft in left extremity)
LeMaitre Vascular Clinical Study Camparing Expedial and ePTFE Vascular Access Grafts in Vascular Access patients - Sponsored by LeMaitre
Vascular
Patient must have vein diameter of 4mm or >
Phase III Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin)
and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostatis - Sponsored by Zymogenetics
PTFE must be used
