Pivotal Trial of the Boomerang Catheter for pDVA

Chronic Limb-Threatening Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06311773
• Other study ID #: Protocol # 24-01
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

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