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Endovascular Graft

Endovascular Graft Repair for Aortic Aneurysm

N/A
Recruiting
Led By Javairiah Fatima, MD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new device to treat complex aortic aneurysms and thoracoabdominal aortic aneurysms in high-risk patients. The trial will assess the safety and preliminary effectiveness of the device, as well as renal function, radiation exposure, and quality of life.

Who is the study for?
This trial is for adults with large aortic aneurysms who are at high risk for open surgery. Candidates must have a life expectancy over 2 years, compatible anatomy for the device, and no severe allergies to device materials. Pregnant or breastfeeding individuals, those with certain connective tissue diseases or infections, and those unable to undergo imaging tests due to body size are excluded.Check my eligibility
What is being tested?
The study is testing a modified Cook Alpha Thoracic Endovascular Graft in patients with complex aortic aneurysms. It aims to evaluate the safety and initial effectiveness of this custom-fit graft designed by physicians specifically for each patient's unique anatomy.See study design
What are the potential side effects?
Potential side effects may include complications related to the endovascular procedure such as blood vessel damage, infection risks from implanting the device, kidney function impairment due to contrast media used during imaging tests, and radiation exposure from X-rays.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My doctor thinks my aneurysm is at high risk of bursting.
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My blood vessels in the hip or thigh area are suitable for medical procedures.
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My aortic aneurysm is due to a tear in the aorta's wall.
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I am at high risk for complications if I undergo open surgery.
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My aneurysm has grown at least 0.5 cm in a year.
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My aortic aneurysm is larger than 5.5 cm or twice the normal size.
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I have a painful aneurysm near or above my kidneys or in my chest and abdomen area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from Major Adverse Events (MAE) at 30 days
Proportion of study subjects with treatment success at 1 year
Technical success
Secondary outcome measures
Quality of Life measures

Trial Design

1Treatment groups
Experimental Treatment
Group I: Endovascular repairExperimental Treatment1 Intervention
Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft.

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
115,461 Total Patients Enrolled
Javairiah Fatima, MDPrincipal InvestigatorMedstar Washington Hospital Center

Media Library

Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft (Endovascular Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04526938 — N/A
Thoracoabdominal Aortic Aneurysms Research Study Groups: Endovascular repair
Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft Highlights & Side Effects. Trial Name: NCT04526938 — N/A
Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft (Endovascular Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526938 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation taking on new participants?

"Affirmative. Clinicaltrials.gov documents corroborate that this medical investigation first advertised on September 20th 2021 is actively seeking volunteers. Approximately 30 patients will be recruited from a solitary research site."

Answered by AI

What is the maximum number of participants for this clinical trial?

"Indeed, the details posted on clinicaltrials.gov show that this trial is actively recruiting volunteers. It was first published on September 20th 2021 and has been modified as recently as September 15th 2022 with a goal of 30 participants across one site."

Answered by AI
~128 spots leftby Sep 2028