Aortoiliac Aneurysms, Infrarenal Abdominal Aortic Aneurysms
Conditions
Keywords
Abdominal Aortic Aneurysm, AAA, Abdominal Aortoiliac Aneurysm, Endovascular Aortic Repair, EVAR
Brief summary
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years. Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System. Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™ AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac aneurysms. The results of this study will be used as supportive data for CE Marking submission in the European Union (EU). Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizon™ AAA Stent graft System. Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance endpoints include successful delivery and deployment of the device; and absence of the following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration. Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular access techniques and devices. Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic Aneurysm Stent graft System.
Detailed description
Possible benefits: It is believed that the Horizon™ AAA Stent Graft System implantation may offer a number of benefits over conventional and recently developed treatment options for patients suffering from AAA. These other treatment modalities include open surgery and the more recently evolved EVAR. The Horizon™ AAA Stent graft System has a low profile of 14Fr and is implanted through a percutaneous approach. The modular bottom-up construction requires a single-sided femoral access and there is no need for cannulation of the contralateral limb, a requirement present in the majority of commercially available devices. These features are anticipated to result in a simplified procedure with less surgical trauma, shorter procedure time, lower levels of radiation exposure and shorter hospitalization periods. Moreover, the device is flexible enough to reach also tortuous anatomies and its fixation elements reduce the concern of migration and type I endoleaks. As such, it is believed that the Horizon™ AAA Stent graft System may have potential clinical advantages and may exhibit benefits over commercially available stent-grafts. Hypothesis: In this clinical study safety and performance primary endpoints are compared between HORIZON™ and those reported for the Lifeline Registry of Endovascular Aneurysm Repair (Control).
Interventions
DEVICEHorizon™ Abdominal Aortic Aneurysm Stent Graft System
All patient eligible to undergo stent implantation will receive the Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.
Sponsors
Endospan Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 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: 1. pregnant (as determined by a positive pregnancy test performed between 10 to 5 days before implantation date), or 2. intend to become pregnant during the study period, or 3. do not accept to use adequate double barrier contraception methods for the entire study duration to avoid pregnancy 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, such as, saccular aneurysm, aneurysm with isolated wall protrusion and penetrating ulcers of the aorta. 6. A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma. 7. Presence of thrombus or atheroma in proximal aortic neck covering \>50% of the endoluminal surface. 8. Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<6mm. 9. Congenital vascular disease in which the placement of the stent graft will cause occlusion of major arterial flow. 10. Aneurysm with any of the following characteristics: suprarenal, isolated ilio-femoral, mycotic, inflammatory or para-anastomotic pseudoaneurysm. 11. Patient has an untreated thoracic aneurysm \> 5.5 cm in diameter. 12. Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries. 13. Patient has a reversed conical neck defined as a \> 4mm distal increase over a 10 mm length. 14. Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow. 15. 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). 16. Patient underwent major surgery or interventional procedure in the last three months. 17. Patient is suffering from unstable angina. 18. Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation. 19. Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. 20. Contraindication to undergoing angiography. 21. Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester. 22. Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta. 23. Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes). 24. Patient has a history of bleeding diathesis or coagulopathy. 25. 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). 26. Acute renal failure documented by either one of the following: Creatinine \> 2.00 mg/dl or \> 182 pmol/L; patient on dialysis. 27. 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. 28. Active participation in another research study involving an investigational device or new drug. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: Major Adverse Events (MAEs) | 1 month post implantation | Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC). |
| Performance Endpoint | 1 month post implant | 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
| Measure | Time frame | Description |
|---|---|---|
| MAEs | 1 month - 5 years post implantation | Proportion of patients free from MAEs at 1 month through 5 years post implantation. |
| Mortality | 12 months | All-cause mortality and aneurysm-related mortality at 12 months, Kaplan-Meier survival analysis. |
| Secondary Performance Endpoint | 12 months post implantation | 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. |
Countries
Italy, Netherlands, Serbia, Switzerland
Participant flow
Recruitment details
Study population included 30 patients enrolled in Hospitals, enrollment period lasted 1 year.
Pre-assignment details
There were no events occurring after patient enrollment and before assignment of the single arm foreseen by the study protocol
Participants by arm
| Arm | Count |
|---|---|
| HORIZON AAA Stent Graft All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Open repair of aneurysm | 1 |
Baseline characteristics
| Characteristic | HORIZON AAA Stent Graft | — |
|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 7.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Italy | 12 participants | — |
| Region of Enrollment Netherlands | 2 participants | — |
| Region of Enrollment Serbia | 11 participants | — |
| Region of Enrollment Switzerland | 5 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 30 |
| other Total, other adverse events | 18 / 30 |
| serious Total, serious adverse events | 19 / 30 |
Outcome results
Primary
Performance Endpoint
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.
Time frame: 1 month post implant
Population: All subjects for whom the implantation procedure was initiated and for whom there were no major entry violations likely to affect outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HORIZON AAA Stent Graft | Performance Endpoint | 30 Participants |
95% CI: [88.4, 100]
Primary
Safety Endpoint: Major Adverse Events (MAEs)
Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC).
Time frame: 1 month post implantation
Population: The safety analysis population consisted of all subjects for whom the implantation procedure was initiated (i.e. date of implantation was not missing).~Out of the 30 subjects in the safety analysis set, none had Major Adverse Events (MAEs) within 1 month, and therefore the sample proportion of subjects having MAE's within 1 month is 0%. The 95% confidence interval is \[0%, 11.6%\], meaning that we are 95% confident that the proportion of subjects having MAE's within 1 month is lower than 11.6%.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HORIZON AAA Stent Graft | Safety Endpoint: Major Adverse Events (MAEs) | 30 Participants |
95% CI: [0, 11.6]
95% CI: [0, 11.6]
Secondary
MAEs
Proportion of patients free from MAEs at 1 month through 5 years post implantation.
Time frame: 1 month - 5 years post implantation
Population: All patients for whom the implantation procedure was initiated and for whom there was no major entry violation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HORIZON AAA Stent Graft | MAEs | 24 Participants |
95% CI: [61, 92]
Secondary
Mortality
All-cause mortality and aneurysm-related mortality at 12 months, Kaplan-Meier survival analysis.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HORIZON AAA Stent Graft | Mortality | 93.3 percentage free from mortality |
Secondary
Secondary Performance Endpoint
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.
Time frame: 12 months post implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HORIZON AAA Stent Graft | Secondary Performance Endpoint | 28 Participants |