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due to lack of interest
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INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCRAFT | Endovascular abdominal aortic aneurysm repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCRAFT | Device | Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of major adverse events | MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure. | Within 30-days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of major adverse events | MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure. | Through 1 year post-procedure |
| Technical success |
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Inclusion Criteria:
Exclusion Criteria:
The subject has one of the following conditions:
Known to be allergic or intolerant to nickel titanium (Nitinol), polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE);
Known contraindication to undergoing angiography or anticoagulation
Existing AAA surgical graft and/or a AAA stent-graft system;
Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial;
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Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
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| Name | Affiliation | Role |
|---|---|---|
| Zhong Chen, Doctor | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The technical success at the end of the first surgery, which was defined as the successful insertion of the delivery system and the successful placement of the device at the desired location.
| At the conclusion of the index procedure |
| Absence of stent graft migration(>10mm) | Stent graft migration is defined as evidence of proximal or distal movement of the stent graft > 10mm relative to fixed anatomical landmarks compared with the 1 month size measurement. | Assessed at 1 year |
| Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm) | Endoleak is defined as a persistent blood flow outside the lumen of the endoluminal graft but within an aneurysm sac or adjacent vascular segment being treated by the device. They are the result of incomplete sealing, or exclusion of the aneurysm sac, and thus cause reflux of blood flow into the sac. Aneurysm enlargement is defined as an increase in maximum aneurysm cross sectional diameter greater than 5mm compared to a baseline measurement, or any subsequent measurement following baseline. | Assessed at 1 year compared to size measurement at 1 month |
| Absence of stent graft fracture | Stent-graft fracture is defined as stent skeleton fracture and barb separation. | Assessed within 30-days and 1-year post-procedure |
| Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture | Stent occlusion is defined as a complete absence of flow, within the AAA stent graft (aortic bifurcate or one or both iliac limbs). | Within 1-year post-procedure |
| Absence of all-cause mortality and aneurysms-related death | Aneurysms-related death is defined as a death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair or death from any subsequent procedure required to treat the same aneurysm. | Within 1-year post-procedure |
| D001018 |
| Aortic Diseases |