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The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
In this study, patients will be observed who receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm. The E-tegra Stent Graft will be implanted at the discretion of the treating physician.
Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft. Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study. All patients will be asked to complete questionaires focussing on the health status (HS) (SF-12) and Quality of Life (QoL) (WHOQOL-BREF).
The period of data collection will be approximately 60 months from the date of intervention for each patient. Source document verification will be performed on 100% of the patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans as well as other imaging files (e.g. CEUS, MRT) will be sent to a CoreLab for independent second evaluation. There is no CoreLab screening before inclusion. All adverse events defined prior to study start, will be adjudicated by the Clinical Evaluation Committee (CEC).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Repair | Device | Endovascular repair of the infrarenal aorta using a AAA stent graft. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all-cause mortality | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all-cause mortality | 24 hours, 12, 24, 36, 60 months |
| Aneurysm-related mortality | Rate of aneurysm-related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients with asymptomatic infrarenal aortic aneurysm who are eligible for the endovascular treatment with the E-tegra Stent Graft System in accordance to the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Michel MP Reijnen, Prof. | Rijnstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | 6815 | Netherlands |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 30-day, 12, 24, 36, 60 months |
| Aneurysm rupture-related mortality | Rate of aneurysm rupture-related mortality | 30-day, 12, 24, 36, 60 months |
| Technical success | Rate of patients with device technical success | 24 hours |
| Clinical success | Rate of patients with clinical success | 12 months |
| Reintervention | Rate of patients with any reintervention | 30-day, 12, 24, 36, 60 months |
| Reintervention-free survival | Rate of patients with reintervention-free survival | 12 months |
| Primary limb patency | Rate of patients with primary E-tegra Stent Graft limb patency | 30-day, 12, 24, 36, 60 months |
| Secondary limb patency | Rate of patients with secondary E-tegra Stent Graft limb patency | 30-day, 12, 24, 36, 60 months |
| Stable aneurysm size | Rate of patients with stable aneurysm size | 12, 60 months |
| Decreasing aneurysm size | Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter) | 12, 60 months |
| Increasing aneurysm size | Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter) | 12, 60 months |
| Major adverse events | Rate of patients with major adverse events (aneurysm-related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke (mRS ≥ 2), visceral ischemia (bowel ischemia with surgical/endovascular intervention or submission to ICU or bowel necrosis with surgical/endovascular intervention or submission to ICU), new hepatic infarction, new chronic (> 90 days) renal insufficiency/renal failure requiring dialysis, new permanent (> 30 days) paraplegia (modified Tarlov Scale ≤ 2), new permanent (> 30 days) paraparesis (modified Tarlov Scale 3 or 4), lower limb ischemia (increase in Rutherford classification) | 30-day, 12, 24, 36, 60 months |
| Endoleak Type Ia | Rate of patients with Type Ia endoleak | 12, 60 months |
| Endoleak Type Ib | Rate of patients with Type Ib endoleak | 12, 60 months |
| Endoleak Type II | Rate of patients with Type II endoleak | 12, 60 months |
| Endoleak Type III | Rate of patients with Type III endoleak | 12, 60 months |
| Endoleak Type IV | Rate of patients with Type IV endoleak | 12, 60 months |
| Endoleak of unknown origin | Rate of patients with endoleak of unknown origin | 12, 60 months |
| Stent graft migration | Rate of patients with stent graft migration > 10 mm | 12, 60 months |
| Dislodgement | Rate of patients with stent graft dislodgement (full component separation) | 30-day, 12, 24, 36, 60 months |
| Stent fracture | Rate of patients with stent fracture | 12, 60 months |
| Stent graft infection | Rate of patients with stent graft infection | 30-day, 12, 24, 36, 60 months |
| Health status | Rate of patients with the same level of health status as prior to surgery | 6, 12, 48 to 60 months |
| QoL | Rate of patients with the same level of QoL as prior to surgery | 6, 12, 48 to 60 months |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |