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The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:
The primary objective of the clinical investigation Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system | Device | A Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events | The proportion of patients that experience a rate of Major Adverse Events | Up to 30 days |
| Effectiveness | Technical Success, defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved.
| Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of the safety events |
| Up to 5 years |
| Technical Success |
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Inclusion Criteria:
All patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Patient is ≥ 18 years of age
Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
Patient has juxtarenal aortic neck angulation ≤ 60°
Target branch vessel diameter ≥ 5 mm.
Patient must be willing to comply with all required follow-up exams.
Exclusion Criteria:
Patients that meet ANY of the following are not eligible for enrollment into the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuki Kuramochi, BSN, RN | Contact | 216-445-4063 | kuramoy@ccf.org | |
| Jeannine Ramsey, BSN, RN | Contact | RAMSEYJ8@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Sean P Lyden, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D001019 | Aortic Rupture |
| ID | Term |
|---|---|
| D017542 | Aneurysm, Ruptured |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Technical Success is a composite of the following:
| Up to 30 days |
| Stent Graft Migratoin | Occurrence of stent graft migration >10 mm | Up to 5 years |
| All Endoleaks | Occurrence of endoleaks (all types, including Type I and III) | Up to 5 years |
| AAA Enlargement | Occurrence of AAA enlargement | Up to 5 years |
| Patency Related Events | Occurrence of patency related events | Up to 5 years |
| Device Integrity Failure | Occurrence of device integrity failure | Up to 5 years |
| Conversion to Open Repair | Occurrence of Conversion to open repair | Up to 5 years |
| Secondary Intervention | Occurrence of Secondary intervention (reason and type) | Up to 5 years |
| D001014 |
| Aortic Aneurysm |
| D001018 | Aortic Diseases |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |