Clinical trial NCT06311773: Pivotal Trial of the Boomerang Catheter for PDVA
Official title: Pivotal Multicenter Trial of the Boomerang™ Catheter for Percutaneous Deep Vein Arterialization (pDVA)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Limb-Threatening Ischemia
Lead sponsor: Aveera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patient is age ≥ 18 years
2. 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.
3. 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.
4. Inflow artery criteria:

   • Imaging confirmation of patent inflow artery (\< 50% stenosis) from Aortic bifurcation to tibial trifurcation.
5. 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.
6. Patient may be scheduled for a planned minor amputation (toe, ray, or trans-metatarsal) within 30 days after index procedure.
7. Prior stent(s) to inflow arteries (i.e., Iliac, SFA, Popliteal) are allowed.
8. Patient is willing and able to provide written informed consent.
9. Patient meets institutional criteria for procedure clearance and is able to comply with study requirements per PI judgement.
10. Diabetic patients have adequate glycemic control per investigator judgement.
11. Female patients of childbearing potential have a negative pregnancy test within 7 days prior to index procedure (urine)
12. 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.
13. PI determines that the primary wound is stable (e.g., not rapidly deteriorating or showing signs of healing).

Exclusion Criteria:

1. Life expectancy \< 12 months.
2. 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).
3. Patient is dialysis dependent.
4. Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in patients not undergoing dialysis.
5. Prior peripheral arterial bypass procedure on index limb within 30 days.
6. Previous major amputation of the target limb or absence of adequate viable tissue for below-ankle (e.g., mid-foot) amputation.
7. Above-ankle amputation of contralateral limb.
8. The patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
9. 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.
10. 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.
11. Patient has had a stroke within the previous 3 months with residual Rankin score of ≥ 2.
12. NYHA Class IV heart failure which may compromise patient's ability to safely undergo a percutaneous procedure, per PI judgment.

Primary outcomes:
measure: Amputation Free Survival (AFS)
timeFrame: 6-months
Secondary outcomes:
measure: Technical success
timeFrame: During index procedure
measure: Procedural success
timeFrame: Immediately post index procedure
measure: Limb salvage
timeFrame: 3 years post index procedure
measure: Primary patency
timeFrame: 1 year post index procedure
measure: Primary assisted patency
timeFrame: 1 year post index procedure
measure: Secondary patency
timeFrame: 1 year post index procedure
measure: Target wound healing
timeFrame: 1, 3, 6, 9-months, and 1-year
measure: Complete wound healing
timeFrame: 1, 3, 6, 9-months, and 1-year
Other outcomes:
Locations:
city: Whittier
country: United States
facility: PIH Whittier Hospital
state: California
city: Thorton
country: United States
facility: Advanced Heart and Vein Center
state: Colorado
city: Wilmington
country: United States
facility: EndoVascular Consultants
state: Delaware
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: St. Augustine
country: United States
facility: Advanced Endovascular Institute
state: Florida
city: Galloway
country: United States
facility: Vascular Institute at AMI
state: New Jersey
city: West Orange
country: United States
facility: American Endovascular and Amputation Prevention
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Murphy
country: United States
facility: Sunrise Vascular
state: North Carolina
city: Tigard
country: United States
facility: Advanced Vascular Centers
state: Oregon
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
city: Houston
country: United States
facility: HOPE Vascular and Podiatry
state: Texas
city: Seattle
country: United States
facility: University of Washington Medicine
state: Washington
Study officials:
References: