Safety and Efficacy of the URECA CTO Device

A Clinical Study Investigating the Safety and Efficacy of the URECA CTO Device

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: URECA CTO device

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 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3083 AN
      • Ikazia Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: URECA CTO device; 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; facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature with the URECA CTO device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	device related complications that involve a Adverse Event.	6 weeks after surgery
procedure time	time whole procedure takes using the URECA CTO device	during surgery
Total Fluoroscopy Time and	The amount of time of fluoroscopy between the time of introducer sheath puncture up to the moment of sheath removal	during surgery
Total Contrast Load	the amount of contrast load between the time of introducer sheath puncture up to the moment of sheath removal	during surgery

Collaborators and Investigators

• Sponsor: Ureca BV
• Investigators: Principal Investigator: JW Kuiper, MD, Ikazia Ziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: URECA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No