By InvitationNot Applicable

Pivotal Trial of the Boomerang Catheter for pDVA

United States120 participantsStarted 2024-04-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. Target conduit vein criteria:
✓. 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.

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.

What they're measuring

Amputation Free Survival (AFS)

Timeframe: 6-months

Trial details

NCT IDNCT06311773

SponsorAveera Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Chronic Limb-Threatening Ischemia trials