A clinical study investigating the safety, efficacy and performance of the URECA CTO device.

Completed

• Conditions: Arteriosclerosis; Chronic Total Occlusion(s); 10003216

• Registration Number: NL-OMON55292
• Lead Sponsor: reca B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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;
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, unless stent is open, placed
more then 6 months before and can be safely passed in the investigator's
opinion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified