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Safety and Efficacy of the URECA CTO Device

Primary Purpose

Peripheral Vascular Disease

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

URECA CTO device

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ikazia ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

URECA CTO device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

safety of device

absence of device related Serious Adverse Events.

Secondary Outcome Measures

Adverse Events

device related complications that involve a Adverse Event.

procedure time

time whole procedure takes using the URECA CTO device

Total Fluoroscopy Time and

The amount of time of fluoroscopy between the time of introducer sheath puncture up to the moment of sheath removal

Total Contrast Load

the amount of contrast load between the time of introducer sheath puncture up to the moment of sheath removal

Full Information

NCT ID

NCT04385381

First Posted

May 6, 2020

Last Updated

October 2, 2023

Sponsor

Ureca BV

1. Study Identification

Unique Protocol Identification Number

NCT04385381

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

change of manufacterer of medical device

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

September 27, 2023 (Actual)

Study Completion Date

September 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ureca BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

URECA CTO device

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

URECA CTO device

Intervention Description

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

Primary Outcome Measure Information:

Title

device success,

Description

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.

Time Frame

during surgery

Title

safety of device

Description

absence of device related Serious Adverse Events.

Time Frame

6 weeks after surgery

Secondary Outcome Measure Information:

Title

Adverse Events

Description

device related complications that involve a Adverse Event.

Time Frame

6 weeks after surgery

Title

procedure time

Description

time whole procedure takes using the URECA CTO device

Time Frame

during surgery

Title

Total Fluoroscopy Time and

Description

The amount of time of fluoroscopy between the time of introducer sheath puncture up to the moment of sheath removal

Time Frame

during surgery

Title

Total Contrast Load

Description

the amount of contrast load between the time of introducer sheath puncture up to the moment of sheath removal

Time Frame

during surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JW Kuiper, MD

Organizational Affiliation

Ikazia Ziekenhuis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ikazia ziekenhuis

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3083 AN

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Efficacy of the URECA CTO Device

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