The primary objectives of the study are to evaluate the safety and performance of the Horizon* AAA Stent Graft System.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoint includes a proportion of patients free from MAEs within 1 month
post implantation, as adjudicated by an independent clinical events committee
(CEC).
MAE is defined as: all-cause mortality, myocardial infarction, renal failure,
respiratory failure, paraplegia, stroke, bowel ischemia and procedural blood
loss >= 1000ml.
Performance endpoints will assess the rate of successful aneurysm treatment at
1 month, defined as:
- Successful delivery and deployment of the device.
- Absence of the following, as determined by an independent core-lab: aneurysm
growth >=5mm, type I or III endoleaks, stent graft occlusion, conversion to open
surgery, rupture and clinically significant stent graft migration.
Secondary outcome
Proportion of patients free from MAEs at 1 month through 5 years post
implantation.
All-cause mortality and aneurysm-related mortality through 1 and 12 months,
Kaplan-Meier survival analysis.
Absence of all of the following at 1 year: aneurysm growth >=5mm, type I or III
endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent
graft migration.
Clinical utility outcomes:
• Procedure duration
• Fluoroscopy time and contrast medium volume
• Estimated blood loss & requirement for blood transfusion
• Time spent in the intensive care unit (ICU)
• Length of hospital stay extending from index procedure to discharge
Background summary
An aneurysm is a swelling or dilation of a weakened wall in an artery involving
one or several segments: the affected segment shows a saclike widening in part
of its tubular form. Aneurysms are usually caused by atherosclerosis,
hypertension, sometime by trauma or infection (mycotic aneurysm). Also genetic
factors probably play a role in the disease as well as smoking and poor diet.
Aneurysm occurs most often in the aorta: when the affected part of the aorta is
its abdominal part, the disease is called *Aortic Abdominal Aneurysm* (AAA,
pronounced *triple a*). AAA is the most common aneurysm affecting the aorta.
AAA is defined as an outer diameter of the aorta, about 50% higher than the
normal non dilated vessel diameter [Isselbacher, 2001].
AAA presents predominately in later life with prevalence of 5% in men over the
age of 65. The prevalence increases with age in both sexes however remains
higher in men than in women. The natural history of the AAA is that of a
continuing growth. The major complication of the AAA is rupture of the artery
wall, and the subsequent massive bleeding into the abdominal cavity. The AAA
rupture is life threatening. Moreover, the rate of aneurysm rupture and death
could exceed 60% within three years of the initial diagnosis [Droc et Al., 2011]
Beside the conservative management of the AAA including surveillance and
medication, the treatment of the AAA may be the repair of the AAA, to prevent
its progressive expansion and its rupture. In the USA, 40 000 patients undergo
elective procedures to repair AAA each year [McPhee, Hill and Eslami , 2007],
resulting in about 1250 perioperative deaths [Ghaferi AA, Birkmeyer JD, Dimick,
2009]. There are two procedural options for the repair of the aneurysm: the
Open Repair (OR) and the EndoVascular Aneurysm Repair (EVAR).
EVAR is less invasive and is thought to be an alternative to OR in patients
that are not eligible to OR due either to their great age or to co-morbidities.
The question has been posed whether it could be also an alternative to
surveillance and conservative management in younger patients and patients with
AAA of a diameter smaller than the actual threshold of 5.5 cm. Beside, whereas
early clinical data show lower perioperative (30 days post operation or
in-hospital stay) and mid-term mortality in EVAR than in OR, the EVAR
advantages on OR in long-term mortality remains an open question.
Study objective
The primary objectives of the study are to evaluate the safety and performance
of the Horizon* AAA Stent Graft System.
Study design
This is a prospective, non-randomized, open-label, one arm, interventional
clinical study, sponsored by Endospan Ltd. The study will be conducted in
Europe and in Israel in up to 12 sites. The trial*s primary endpoints will be
evaluated at 30 days, after which data will be submitted to the notified body.
At the same time, all 30 subjects planned for the trial will be followed-up for
five years.
Patients who meet all eligibility criteria and have signed the informed consent
are eligible for this study and will undergo implantation of the Horizon* AAA
Stent graft System.
Data will be collected at baseline, implantation, pre-discharge, 1, 6, and 12
months and annually thereafter until completion of 5 years follow-up. All
adverse events, including deaths, will be recorded throughout the course of the
study. Results of all implanted patients will be collected, analyzed and
reported.
Intervention
AAA HORIZON TM Stent Graft System implantation.
Study burden and risks
As with all medical interventions, there are possible risks and side effects
and it is anticipated that the risks and side effects of the Horizon*
stentgraft are not different than other comparable medical devices used for
abdominal aneurysms.
Risks of stentgraft surgery in general include: leakage of blood around the
stentgraft, blockage of the bloodstream through the stentgraft, displacement of
the stentgraft compared to its original position and infection. In case the
stentgraft is not placed correctly, the abdomen has to be opened anyway in
order to place a tube prothesis.
Also, the normal risks of complications during an intervention are present,
such as bleeding, infection of the wound, thrombosis or pneumonia.
It is also possible that unexpected events occur.
There are always precautionary taken (in the way the stentgraft is made, during
surgery and the care you receive after surgery) to reduce the risks that could
occur when placing a stent where possible. The physician will discuss these
potential risks and benefits with the patient.
Maskit St. 4
Herzliya 46733
IL
Maskit St. 4
Herzliya 46733
IL
Listed location countries
Age
Inclusion criteria
1. Male and female age >= 18.
2. Presence of at least one of the following:
i. Abdominal aortic aneurysm >= 5.0cm in diameter (perpendicular to the line of flow).
ii. Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - >= 0.5cm over 6 months or 1.0cm over one year.
iii. Abdominal aortic aneurysm >50% larger than the normal aortic diameter.
3. Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
4. Femoral artery diameter of >=6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
5. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
6. To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging:
I. Infrarenal aortic neck diameter of 18-28 mm
II. Aortic length (lower renal artery to lowest point of aortic bifurcation) of 115-150 mm
III. Iliac artery diameter of 10-19 mm
IV. Proximal aortic neck length >= 15 mm
V. Proximal aortic neck/ aneurysm angulation <= 60°
VI. Diameter measured 20mm above aortic bifurcation floor should be >= 20mm
VII. Aortic bifurcation angulation of >= 70°.
7. Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document.
Exclusion criteria
1. If female and of childbearing potential, patients who are:
a. less than 5 years post-menopausal or did not undergo hysterectomy, oophorectomy or tubal ligation and do not agree to take all measures to avoid pregnancy during the period of the study.
b. nursing.
2. Life expectancy of less than 1 year.
3. Any medical condition that, according to the investigator*s decision, might expose the patient to increased risk by the investigational device or procedure.
4. Patient is in need for an emergent surgery for a ruptured aneurysm.
5. Patient with an increased risk for aneurysm rupture during the procedure.
6. An Acutely ruptured or leaking aneurysm.
7. Acute traumatic dissection or vascular injury or penetrating ulcers of the aorta.
8. Presence of thrombus or atheroma in proximal aortic neck covering >50% of the endoluminal surface.
9. Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to <6mm.
10. Congenital vascular disease in which the placement of the stent graft will cause occlusion of major arterial flow.
11. Aneurysm with any of the following characteristics: suprarenal, isolated ilio-femoral, mycotic, inflammatory or para-anastomotic pseudoaneurysm.
12. Patient has an untreated thoracic aneurysm > 5.5 cm in diameter.
13. Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
14. Patient has a reversed conical neck defined as a > 4mm distal increase over a 10 mm length.
15. Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
16. Patient whose arterial access site is not anticipated to accommodate the 14 Fr diameter of the Horizon* Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture).
17. Patient underwent major surgery or interventional procedure in the last three months.
18. Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above.
19. Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation.
20. Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
21. Contraindication to undergoing angiography.
22. Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester.
23. Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
24. Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes).
25. Patient has a history of bleeding diathesis or coagulopathy.
26. Active systemic infection at the time of the index procedure documented by either one of the following: pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3).
27. Acute renal failure documented by either one of the following: Creatinine > 2.00 mg/dl or > 182 umol/L; patient on dialysis.
28. Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
29. Active participation in another research study involving an investigational device or new drug.
Design
Recruitment
Medical products/devices used
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 | NCT02087501 |
| CCMO | NL47220.060.13 |