Safety and Efficacy of the URECA CTO Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions

NCT04710342

Chronic Total Occlusion

UNKNOWN NA

Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality

NCT03594175

Catheter Occlusion Thrombosis

TERMINATED PHASE3

Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters

NCT02770560

Kidney Failure, Chronic Vascular Access Devices

COMPLETED

USING THE ACCUVEIN DEVICE FOR PATIENTS WHO ARE DIFFICULT TO PERFUSE

NCT06861595

Patient Who Are Difficult to Infuse

NOT_YET_RECRUITING NA

A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

NCT05386342

Thrombus Embolus Occlusion; Vessel

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

URECA CTO device

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

URECA CTO device

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No