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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06311773
Other study ID # Protocol # 24-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 15, 2024
Est. completion date January 15, 2029

Study information

Verified date March 2024
Source Aveera Medical, Inc.
Contact Chris Chapek
Phone 440-567-1793
Email cchapek@aveeramedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date January 15, 2029
Est. primary completion date January 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Patient is age = 18 years and = 85 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.

Study Design


Related Conditions & MeSH terms

  • Chronic Limb-Threatening Ischemia
  • Ischemia

Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aveera Medical, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6-months
Secondary 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. During index procedure
Secondary Procedural success confirmation of retrograde fistula flow in the target tibial vein conduit at index procedure completion. Immediately post index procedure
Secondary Limb salvage Freedom from above-ankle amputation of the index limb. 3 years post index procedure
Secondary Primary patency Time from fistula creation to the first intervention to maintain or reestablish flow through the fistula or to fistula occlusion. 1 year post index procedure
Secondary Primary assisted patency Time from fistula creation to the first occlusion of the fistula. 1 year post index procedure
Secondary Secondary patency Time from fistula creation to abandonment (e.g., decision to decline intervention due to occlusion) of the fistula. 1 year post index procedure
Secondary Target wound healing Complete or in-process healing of the patient's target wound(s). 1, 3, 6, 9-months, and 1-year
Secondary Complete wound healing Complete healing of all the patient's ischemic wound(s) in the index limb. 1, 3, 6, 9-months, and 1-year
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