An interventional study of Physician Modified Aortic Endograft repair for complex aortic aneurysm in Juxta Renal Abdominal Aortic Aneurysm Without Rupture, Complex Aortic Aneurysms and Aortic Aneurysm, sponsored by Akhilesh Jain. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Akhilesh Jain · Not applicable, Interventional, and Treatment
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
The primary intent of the study is to assess safety and preliminary effectiveness of the physician modified endografts 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).
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 15 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →This is the only study on the registry with Akhilesh Jain as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
Exclusion Criteria:
Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Physician Modified Aortic Endograft repair for complex aortic aneurysm
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.
Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure.
The Primary Safety Endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure. Major Adverse Events that will be recorded include the following: * All-cause mortality * Myocardial Infarction * Stroke * Renal Failure * Respiratory Failure * Paraplegia * Bowel Ischemia * Procedural Blood Loss (\> 1000cc)
Time frame: 30 days
Primary Effectiveness Endpoint: Will be measured by calculating the proportion of patients that achieve Treatment Success
Effectiveness of the PMEG device will be measured by the calculating the proportion of subjects that achieve Treatment Success. Treatment Success is a will be assessed at 12 months and is define by a combination of following criteria to be met: * Technical Success (at the index procedure). * Freedom from Type I \& III endoleaks at 12 months * Freedom from stent graft migration at 12 months * Freedom from aortic aneurysm enlargement at 12 months * Freedom from aortic aneurysm rupture and conversion to open repair through 12 months Technical Success at the index procedure will be defined by: The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved.
Time frame: 12 months
Secondary Safety Endpoints: Will be assessed by measuring proportion of patients encountering any of the following adverse events
The adverse events will be evaluated at 30 days, 6 months, 12 months following the initial implant procedure and annually through 5 years. The adverse events to be evaluated include: * Mortality * Aneurysm related mortality * Aneurysm rupture * Major Adverse Events (MAE) * Renal Failure with or without permanent dialysis * Graft infection
Time frame: Through 5 years
Secondary Effectiveness Endpoints: Defined by proportion of patients experiencing the following events.
The secondary effectiveness endpoints will be evaluated at 30 days, 6 months, 12 months following the initial implant procedure and annually through 5 years: Following secondary endpoints will be evaluated for every patient: * Technical Success (evaluated at 30-days) * Stent graft migration (\>10 mm) * All endoleaks, including Type I \& III endoleaks * AAA enlargement * Patency related events * Device integrity failure * Conversion to open repair * Secondary intervention (reason and type)
Time frame: Through 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.
Of 44 interventional studies with no phase under Aortic Aneurysm, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's planned 23 months is below that.
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