Safety and Efficacy of the URECA CTO Device

Ureca

Status: Terminated

Conditions: Peripheral Vascular Disease

Treatments: Device: URECA CTO device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04385381

URECA

Details and patient eligibility

About

Clinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.

Full description

Peripheral Arterial Disease (PAD) restricts blood supply to the lower limbs. The disease causes obstructions that can affect blood vessels in both the proximal and distal regions. When these vessel obstructions exist for more than 3- 6 Months they are classed as chronic total occlusions. Without sufficient collateral formation this can lead to to chronic limb-treatening ischemia (CLTI), which is characterized by chronic pain and tissue loss. Without revascularization this frequently leads to amputation. The purpose of this clinical study is to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.

Enrollment: 11 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be >= 18 and <= 85 years old
• Clinically diagnosed for endovascular treatment of peripheral vascular disease and chronic total occlusion in the iliac artery, superficial femoral artery or in the proximal popliteal artery determined by duplex, CTA, MRA and/or DSA.
• Patient has been assessed by an independent vascular surgeon and an interventional radiologist.
• Written and signed informed consent

Exclusion criteria

• 1. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy; 2. Severe infection or soft tissue loss that may preclude any meaningful attempt at limb salvage; 3. Known or suspected allergies or contraindications to contrast agents; 4. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study; 5. The subject 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; 6. Patient unable to give consent; 7. Pregnant and breastfeeding women; 8. Patients who recently suffered from a stroke and/or a myocardial infarct (Within 2 months) 9. Patients with an uncontrollable diabetes; 10. Severe intercurrent illness that, in the opinion of the investigator, may put the subject at risk when participating in the study 11. Patients with hypercoagulopathy; 12. Stent in place in the to be treated artery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

URECA CTO device

Experimental group

Description:

investigate the safety and efficacy of the URECA CTO device in facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature.

Treatment:

Device: URECA CTO device