Pivotal Trial of the Boomerang Catheter for pDVA

Official title

Pivotal Multicenter Trial of the Boomerang® Catheter for Percutaneous Deep Vein Arterialization (pDVA)

Overview

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.

Interventions

• Device Boomerang Catheter
  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.

Primary outcome measures

• Amputation Free Survival (AFS) [Time frame: 6-months]

Secondary outcome measures (8)

• Technical success [Time frame: During index procedure]
• Procedural success [Time frame: Immediately post index procedure]
• Limb salvage [Time frame: 3 years post index procedure]
• Primary patency [Time frame: 1 year post index procedure]
• Primary assisted patency [Time frame: 1 year post index procedure]
• Secondary patency [Time frame: 1 year post index procedure]
• Target wound healing [Time frame: 1, 3, 6, 9-months, and 1-year]
• Complete wound healing [Time frame: 1, 3, 6, 9-months, and 1-year]

Eligibility criteria

Inclusion criteria

• Patient is age ≥ 18 years
• Patient has confirmed clinical diagnosis of Rutherford Category (RC) 5 or 6 Chronic Limb-Threatening Ischemia (CLTI) with previous angiogram or hemodynamic evidence (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) demonstrating severely diminished arterial perfusion of the index limb.
• Assessment by the PI and an Independent Review Committee (IRC) determines that patient has no option for conventional distal bypass, surgical or endovascular therapy for limb salvage.
• Inflow artery criteria:

• Imaging confirmation of patent inflow artery (< 50% stenosis) from Aortic bifurcation to tibial trifurcation.
• Target conduit vein criteria:

• Duplex ultrasound confirms that vein is free from thrombus, contiguous from the intended anastomosis site through the lateral plantar vein, and ≥ 2.0mm lumen-lumen diameter (with tourniquet applied) throughout.
• Patient may be scheduled for a planned minor amputation (toe, ray, or trans-metatarsal) within 30 days after index procedure.
• Prior stent(s) to inflow arteries (i.e., Iliac, SFA, Popliteal) are allowed.
• Patient is willing and able to provide written informed consent.
• Patient meets institutional criteria for procedure clearance and is able to comply with study requirements per PI judgement.
• Diabetic patients have adequate glycemic control per investigator judgement.
• Female patients of childbearing potential have a negative pregnancy test within 7 days prior to index procedure (urine)
• Patient is enrolled in a wound care network and has an adequate support network to ensure compliance with medication regimen and follow-up study visits.
• PI determines that the primary wound is stable (e.g., not rapidly deteriorating or showing signs of healing).

Exclusion criteria

• Life expectancy < 12 months.
• Patient has a lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).
• Patient is dialysis dependent.
• Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in patients not undergoing dialysis.
• Prior peripheral arterial bypass procedure on index limb within 30 days.
• Previous major amputation of the target limb or absence of adequate viable tissue for below-ankle (e.g., mid-foot) amputation.
• Patient is non-ambulatory due to above-ankle amputation of contralateral limb.
• The patient is currently participating in another investigational drug or device study that has not completed the primary endpoint and that clinically interferes with the endpoints of this study per PI judgement.
• Patient has known hypersensitivity or contraindication to materials used during the procedure (cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers) or a known contrast sensitivity that cannot be adequately pre-medicated.
• Patient cannot be adequately treated with study medications due to known contraindication to aspirin, ADP antagonists such clopidogrel, prasugrel or ticagrelor, or anticoagulants such as heparin or bivalirudin.
• Patient has had a stroke within the previous 3 months with residual Rankin score of ≥ 2.
• NYHA Class IV heart failure which may compromise patient's ability to safely undergo a percutaneous procedure, per PI judgment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 25 centers

• Arrowhead Regional Medical Center — San Bernardino
• Olive View-UCLA Medical Center — Sylmar
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
• PIH Whittier Hospital — Whittier
• EndoVascular Consultants — Wilmington
• First Coast Cardiovascular Institute — Jacksonville
• Rush University Medical Center — Chicago
• Cardiovascular Institute of the South — Houma
• … and 17 more centers

Identifiers

NCT: NCT06311773 · Protocol # 24-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗