Safety and Efficacy of the URECA CTO Device

Not Applicable

Terminated

• Conditions: Peripheral Vascular Disease
• Interventions: Device: URECA CTO device

• Registration Number: NCT04385381
• Lead Sponsor: Ureca BV

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.

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 Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2020-12-01
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
URECA CTO device	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.

Primary Outcome Measures

Name	Time	Method
device success,	during surgery	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.
safety of device	6 weeks after surgery	absence of device related Serious Adverse Events.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ikazia ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands