Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01538056
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2012-02-18
Brief Title:
Physician Modified Endovascular Grafts
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Physician Modified Endovascular Grafts for the Treatment of Elective Symptomatic or Ruptured Juxtarenal Aortic Aneurysm An Investigator Initiated Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMEG
Brief Summary:
The primary objectives of this study are to determine whether physician modified endovascular grafts are a safe and effective method of treating patients with elective symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates for open surgical repair and have no other options for treatment
Detailed Description:
15000 Americans die suddenly each year from rupture of an aneurysm in the aortawhich is the ninth leading cause of death in men over age 55 Aortic aneurysms are four times more common in men than in women and usually occur in those over age 50 Approximately one percent of men between the ages of 55 and 64 will have a significant aneurysm and the likelihood increases to about four to six percent of those men over the age of 75 In a recent population-based study of Medicare beneficiaries 832 of patients undergoing endovascular repair of their aortic aneurysm were male Furthermore 119 of patients were 67 to 69 years of age 268 70 to 74 357 75 to 79 158 80 to 84 and 98 85 years of age Ninety-six percent of patients were White 3 Black and the rest either Hispanic or Other We have reason to believe that the current population of patients in the Pacific Northwest harboring abdominal aortic aneurysms match these statistics Thus women and minorities will definitely be under-represented in this study primarily due to the epidemiology of the disease process
Our institution treats a large number of patients with aortic pathology including a large number of patients with symptomatic or ruptured abdominal aortic aneurysms We recently published our results on the implementation of a protocol for managing these patients with endovascular techniques and have been able to reduce the mortality rate in half for the first time in over 30 years Unfortunately not all patients presenting with symptomatic or ruptured aortic aneurysms are candidates for endovascular repair Reasons for exclusion predominantly involve lack of a suitable proximal aortic neck Solutions to this problem involve multi-branched or fenestrated endografts which are being assessed in other clinical trials However grafts in these trials require between 6 and 12 weeks to manufacture and deliver to the investigational site
On-site physician modification has also been described but is currently considered outside the Instructions For Use for the intended devices Our institutions quality improvement department recently performed an objective review of 47 consecutive PMEG cases in patients presenting with asymptomatic symptomatic or ruptured aortic aneurysms with highly encouraging results See Many patients in our region do not have access to clinical trials involving emerging aortic endovascular therapies and some have no other option due to urgent presentation or poor open surgical candidacy For these important reasons we seek to evaluate the safety and efficacy of PMEG using FDA-approved off-the-shelf device in order to increase the applicability of these technologies to more patients and thus save more lives
Our institution treats a large number of patients with aortic pathology including a large number of patients with symptomatic or ruptured abdominal aortic aneurysms We recently published our results on the implementation of a protocol for managing these patients with endovascular techniques and have been able to reduce the mortality rate in half for the first time in over 30 years Unfortunately not all patients presenting with symptomatic or ruptured aortic aneurysms are candidates for endovascular repair Reasons for exclusion predominantly involve lack of a suitable proximal aortic neck Solutions to this problem involve multi-branched or fenestrated endografts which are being assessed in other clinical trials However grafts in these trials require between 6 and 12 weeks to manufacture and deliver to the investigational site
On-site physician modification has also been described but is currently considered outside the Instructions For Use for the intended devices Our institutions quality improvement department recently performed an objective review of 47 consecutive PMEG cases in patients presenting with asymptomatic symptomatic or ruptured aortic aneurysms with highly encouraging results See Many patients in our region do not have access to clinical trials involving emerging aortic endovascular therapies and some have no other option due to urgent presentation or poor open surgical candidacy For these important reasons we seek to evaluate the safety and efficacy of PMEG using FDA-approved off-the-shelf device in order to increase the applicability of these technologies to more patients and thus save more lives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None