AAA - Abdominal Aortic Aneurysm
Conditions
Brief summary
To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or sealing due to an endoleak or migration are at high risk for aneurysm-related complications or who are at high risk of migration or endoleak complications post-procedure, and to support product registration of Heli-FX EndoAnchor system with the National Medical Product Administration (NMPA) in China.
Interventions
DEVICEHeli-FX EndoAnchor System
Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment
Sponsors
Medtronic Cardiovascular
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
* Aged 18 years or older; * Male or non-pregnant female patients; women of childbearing potential must undergo a pregnancy test prior to enrollment, and the result must be negative; * Willing and able to provide written informed consent; * Maximum diameter of the abdominal aortic aneurysm (AAA) ≥ 4.5 cm in females or ≥ 5 cm in males; * Proximal neck diameter of the AAA ranging from 19 to 32 mm; * Distal fixation zone length of both iliac arteries ≥ 15 mm; * Diameter of iliac artery fixation zones on both sides ranging from 8 to 25 mm; * ≤ 60° infrarenal and ≤ 45°suprarenal angulation OR ≤ 75°infrarenal and ≤ 60°suprarenal angulation with proximal necks ≥ 15 mm in length; * Presence of high-risk anatomical criteria, defined as meeting any one of the following criteria: 1. Proximal neck diameter \> 28 mm and ≤ 32mm 2. Proximal neck length ≥ 10 mm and \< 15 mm 3. Neck angulation ≥ 60°and ≤ 75° (angle between the long axis of the proximal neck and the long axis of the aneurysm sac) 4. Conical neck (defined as diameter increased \> 10% compared with the immediate infrarenal diameter over the first 10 mm beyond the lowest main renal artery) 5. Investigator determined subject could benefit from this Heli-FX procedure * Patients deemed by the investigator to be suitable candidates for elective AAA repair; * Patients who agree to return to the treating investigator for all scheduled follow-up visits and are able to attend hospital-based follow-up; * Life expectancy \> 2 years
Exclusion criteria
* Myocardial infarction within the past 3 months; * Systemic infection; * Ruptured or leaking AAA; * Infected or inflammatory AAA; * Known hereditary connective tissue disorders (e.g., Marfan syndrome or Ehlers-Danlos syndrome); * Concomitant thoracic aortic aneurysm or thoracoabdominal aortic aneurysm; * Requirement for emergency AAA repair; * History of prior AAA repair; * Patient body habitus that interferes with required imaging studies; * In the opinion of the investigator, the patient has serious comorbidities that may pose an unacceptable risk for general anesthesia or endovascular intervention; * Planned major surgery (e.g., thoracic aorta, renal, superior mesenteric artery/celiac or lower extremity revascularization, IMA reimplantation, permanent vascular access, cholecystectomy) concurrent with or within 30 days before or after the AAA repair procedure; * Renal failure requiring dialysis; * Patient has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment; * Known hypersensitivity or allergy to polyester, nickel, titanium, tantalum, chromium, molybdenum, and/or cobalt; * Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure; * Bleeding diathesis or hypercoagulable state; * Sealing zone thrombus, calcium or plaque \> 2 mm in thickness or covering \> 50% (180 degrees) of the vessel circumference; * Irregularly shaped calcification and/or plaques at the proximal implantation sites that may interfere with proper deployment of the EndoAnchor implants; * Mental disorders or other conditions that may impair the patient's ability to understand the nature, significance, and/or scope of the study; * Participation in another investigational drug or device trial without having completed the required follow-up. * Endograft planned to be used had not undergone in vitro evaluation to confirm its compatibility with the EndoAnchor implant and the aortic fixation system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | From procedure to 12 months after index procedure | Composite treatment endpoint of Heli-FX within 12 months: * Technical success * No Type Ia endoleak * No endograft migration of proximal stent graft component * No aortic aneurysm rupture |
| Primary Safety Endpoint | within 30 days post-operation | Percentage of patients experiencing one or more major adverse events (MAE) within 30 days post-operation. MAEs are defined as any of the following: * All-cause mortality (ACM) * Heli-FX device-related serious adverse event (SAE) * Myocardial infarction (MI) * Stroke (excluding transient ischemic attacks) * Renal failure (excluding renal insufficiency) * Respiratory failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints | From index-procedure to 3 years | * Technical success and clinical success at the time of index procedure * All-cause mortality and aneurysm-related mortality at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years. * Type Ia endoleak at 30 days, 6 months, one year, and annually through 3 years * Endograft migration at 6 months, one year, and annually through 3 years * Aneurysm sac change by diameter at 6 months, one year and annually through 3 years compared to the CT(Computed Tomography) imaging at 30 days after index procedure * Loss of endograft fabric integrity as a result of the EndoAnchor implant, rupture of the treated aneurys, conversion to open surgical repair at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years * Myocardial infarction, stroke (excluding transient ischemic attacks), renal failure and respiratory failure at 30 days, 6 months, one year, and annually through 3 years |
Countries
China
Contacts
CONTACTFairy Liu
Outcome results
None listed