NL-OMON55292
Completed
Not Applicable
A clinical study investigating the safety, efficacy and performance of the URECA CTO device. - URECA
reca B.V.0 sites40 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arteriosclerosis
- Sponsor
- reca B.V.
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject must be \>\<\= 18 and \<\<\= 85 years old
- •2\. Clinically diagnosed for endovascular treatment of peripheral vascular
- •disease and chronic total occlusion in the iliac artery, superficial femoral
- •artery or in the popliteal artery determined by duplex, CTA, MRA and/or DSA.
- •3\. Patient has been assessed by an independent vascular surgeon and an
- •interventional radiologist
- •4\. 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;
Outcomes
Primary Outcomes
Not specified
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