The objective of the clinical investigation is to 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.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The primary efficacy endpoint is device success, defined as the successful
placement of a guidewire in the true lumen distal of the CTO using the URECA
CTO Device with or without a reentry device, without the occurrence of device
related complications that involve a Serious Adverse Event.
- The primary safety endpoint is the absence of device related Serious Adverse
Events.
The study is considered successful if the guidewire is placed correctly in the
true lumen behind the occlusion in at least 80% of the patients and there are
no more than 10% Serious Adverse Events, with the exception of (possible)
device related death. In the case of (possible) device related death the study
will put on hold until the DSMB has discussed the case and considers the device
save to continue.
Secondary outcome
The secondary endpoints are:
* The successful placement of a guidewire in the true lumen distal of the CTO
using the URECA CTO Device.
* The (per subject) occurrence of device related complications that involve a
Serious Adverse Event.
* (Serious) Adverse Events (up to close out visit)
Adverse Events will be reported according at least to:
-if Adverse Event is Serious
-if Adverse Event is procedure related
-If Adverse Event is device related Expected
(Serious) Adverse Events include, but are not limited to:
* (S)AE resulting in Death
* Vessel perforation Distal vessel occlusion (thrombosis)
* Bleeding complications requiring transfusion
* Amputation
* Procedure Time (for complete procedure)
* Procedure Time (related to URECA CTO device)
* Total Fluoroscopy Time
* Total Contrast Load
Background summary
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.
This is the first clinical investigation of the URECA CTO Device in humans. At
present, the device is not registered or placed on the market in any country,
state or region. The URECA CTO device is intended to provide at least an
equivalent result compared to existing catheter interventions for crossing
(calcified) occluded vessels either via sub-intimal re-entry or spontaneous
re-entry for the placement of a guidewire which facilitates various treatment
options in patients with peripheral vascular disease. In the patient population
of this clinical study, the URECA CTO device will introduce no new or
additional safety risks beyond those associated with in the field widely used
standard recanalization techniques, including recanalization via the subintimal
route.
Study objective
The objective of the clinical investigation is to 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.
Study design
This is a prospective, open-label, multicenter, two arm study, the arms being
the 65 cm (short) URECA CTO device and the 115 cm (long) URECA CTO device. For
the long device 10 subjects will be enrolled. For the short device 30 patients
will be enrolled. Of these 30 patients we expect a re-entry procedure for
approximately 10 patients. Taking into account a maximum attrition rate of 9%
through withdrawal or lost to follow-up 11 subjects for the long device and 33
for the short device are expected to be enrolled before the required number of
subjects is reached. There will be no randomization procedure, the treating
physician will decide which device will be used (short or long) depending on
the procedure. The use of a short or long device depends on the distance
between the access site and the occlusion, It is not always technically
possible to enter in the direction of the occlusion and the practitioner is
forced to gain access on the contralateral side (retrograde approach) (see
7.2).
Intervention
Individual subjects will be followed-up post procedure, one week after the
procedure. The safety is measured via SAEs documented during the procedure
until the close-out visit. It is anticipated that enrollment, follow-up and the
close-out study report will take approximately 18 months to be completed.
Study burden and risks
Participation in the study will last a total of 6 weeks for the patient. At
time of the screening, blood tests will be done and a physical examination will
be performed (such as blood pressure and heart rate). A quality of life
questionnaire will also be conducted during the screening.
There are 2 follow-up checks after the procedure.
- Follow-up visit within 1 week after the procedure. During this 1 hour visit a
physical examination will be performed and an ultrasound will be made. Possible
side effects can also be discussed.
- Close-out visit by telephone within 4-6 weeks after the procedure. Prior to
this telephone call a quality of life questionnaire will be sent to the
patient. Compilation of the questionnaire will take approximately 15 minutes.
The associated risks presented in this study are similar to those of other
interventional and vascular surgical procedures.
Physical risks associated with catheter placement:
* Death (<1%)
* Bleeding (1-2%)
* Arterial thromboembolism (blood clot in another) (<1%)
* Sepsis (blood infection) (1%)
* Infection of the puncture point (1%)
* Perforation (a hole in the wall of a blood vessel, vein or organ) (1%)
* Vascular injury (damage to a blood vessel) (1%)
* Venous thrombosis (blood clot in a blood vessel) (1%)
* Amputation
* Allergic reaction to contrast agent (<1%)
Risks related to anticoagulant medication:
* Bleeding problems
* Headache
* Dizziness
* Pain or discomfort
* Bruising
* Swelling
* Blood in urine or stool
* More bleeding than normal during menstruation
* Change in body temperature
* Visible dark areas on arms or legs
In addition to the general risks, the specific risks associated with the URECA
are:
* Perforation (a hole in the wall of a blood vessel, vein or organ)
* Vascular injury (damage to a blood vessel)
* Arterial thromboembolism
* Release a part of the URECA
The benefit to the subjects enrolled in this study is the potential for
improved blood flow to the foot reducing or eliminating the need for bypass
surgery or in the worst case amputation.The potential benefit of reduced bypass
surgery, procedures times, fluoroscopy and contrast loads and in the worst case
scenario amputation of the foot greatly outweighs the standard
endovascular/surgical risks associated with this procedure.
Beursplein 37
Rotterdam 3011 AA
NL
Beursplein 37
Rotterdam 3011 AA
NL
Listed location countries
Age
Inclusion criteria
1. Subject must be ><= 18 and <<= 85 years old
2. Clinically diagnosed for endovascular treatment of peripheral vascular
disease and chronic total occlusion in the iliac artery, superficial femoral
artery or in the popliteal artery determined by duplex, CTA, MRA and/or DSA.
3. Patient has been assessed by an independent vascular surgeon and an
interventional radiologist
4. 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, unless stent is open, placed
more then 6 months before and can be safely passed in the investigator's
opinion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04385381 |
| CCMO | NL73070.078.20 |