Clinical trial NCT04385381: Safety and Efficacy of the URECA CTO Device
Official title: A Clinical Study Investigating the Safety and Efficacy of the URECA CTO Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Ureca BV
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature with the URECA CTO device.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: device success,
timeFrame: during surgery
measure: safety of device
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 weeks after surgery
measure: procedure time
timeFrame: during surgery
measure: Total Fluoroscopy Time and
timeFrame: during surgery
measure: Total Contrast Load
timeFrame: during surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Ikazia ziekenhuis
state: Zuid-Holland
Study officials:
affiliation: Ikazia Ziekenhuis
name: JW Kuiper, MD
role: PRINCIPAL_INVESTIGATOR
References: