The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The study device used for this procedure makes an anastomosis between a tibial vein and a tibial artery to direct blood flow around blocked arteries.
Olive View-UCLA Medical Center
Sylmar, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Amputation Free Survival (AFS)
Freedom from above-ankle amputation of the index limb or death (any cause) at 6 months, compared to a literature derived performance goal.
Time frame: 6-months
Technical success
Successful deployment of the Boomerang Catheter to the anastomosis site, creation of an anastomosis, and confirmation of fistula flow using angiography or Doppler ultrasound immediately post catheter activation.
Time frame: During index procedure
Procedural success
confirmation of retrograde fistula flow in the target tibial vein conduit at index procedure completion.
Time frame: Immediately post index procedure
Limb salvage
Freedom from above-ankle amputation of the index limb.
Time frame: 3 years post index procedure
Primary patency
Time from fistula creation to the first intervention to maintain or reestablish flow through the fistula or to fistula occlusion.
Time frame: 1 year post index procedure
Primary assisted patency
Time from fistula creation to the first occlusion of the fistula.
Time frame: 1 year post index procedure
Secondary patency
Time from fistula creation to abandonment (e.g., decision to decline intervention due to occlusion) of the fistula.
Time frame: 1 year post index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Torrance, California, United States
PIH Whittier Hospital
Whittier, California, United States
EndoVascular Consultants
Wilmington, Delaware, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Vascular Institute at AMI
Galloway, New Jersey, United States
...and 9 more locations
Target wound healing
Complete or in-process healing of the patient's target wound(s).
Time frame: 1, 3, 6, 9-months, and 1-year
Complete wound healing
Complete healing of all the patient's ischemic wound(s) in the index limb.
Time frame: 1, 3, 6, 9-months, and 1-year