Safety and Efficacy of the URECA CTO Device

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04385381
• Other study ID #: URECA
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: September 27, 2023

Study information

• Verified date: October 2023
• Source: Ureca BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Ikazia ziekenhuis	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Ureca BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	safety of device	absence of device related Serious Adverse Events.	6 weeks after surgery
Secondary	Adverse Events	device related complications that involve a Adverse Event.	6 weeks after surgery
Secondary	procedure time	time whole procedure takes using the URECA CTO device	during surgery
Secondary	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
Secondary	Total Contrast Load	the amount of contrast load between the time of introducer sheath puncture up to the moment of sheath removal	during surgery