Status:
TERMINATED
Safety and Efficacy of the URECA CTO Device
Lead Sponsor:
Ureca BV
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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...
Detailed 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 ob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04385381
Start Date
December 1 2020
End Date
September 27 2023
Last Update
October 5 2023
Active Locations (1)
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1
Ikazia ziekenhuis
Rotterdam, South Holland, Netherlands, 3083 AN