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Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

NCT04526938 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-29

No results posted yet for this study

Summary

The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.

Conditions

  • Juxtarenal Aortic Aneurysm
  • Suprarenal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm

Interventions

DEVICE

Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft

Cook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels.

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Javairiah Fatima, MD · Medstar Health Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526938 on ClinicalTrials.gov