Safety and Efficacy of the URECA CTO Device

NCT04385381 | Terminated DMC

• 1 other identifier: URECA
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 total occlusions) in the peripheral vasculature.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• device success,

  the successful placement of a guidewire in the true lumen distal of the CTO using the URECA CTO Device without the occurrence of device related complications that involve a Serious Adverse Event.

  during surgery

• safety of device

  absence of device related Serious Adverse Events.

  6 weeks after surgery

Secondary Outcomes (4)

• Adverse Events

  6 weeks after surgery

• procedure time

  during surgery

• Total Fluoroscopy Time and

  during surgery

• Total Contrast Load

  during surgery

Study Arms (1)

URECA CTO device

EXPERIMENTAL

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.

Device: URECA CTO device

Interventions

URECA CTO device DEVICE

facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature with the URECA CTO device.

URECA CTO device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Ureca BV: lead

Study Sites (1)

Ikazia ziekenhuis

Rotterdam, South Holland, 3083 AN, Netherlands

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• JW Kuiper, MD

  Ikazia Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature with the URECA CTO device.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 12, 2020
• Study Start: December 1, 2020
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)