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NCT02050113 · ClinicalTrials.gov registry record · NA

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

A NA study of Ehlers-Danlos Syndrome and Marfan Syndrome, sponsored by Andres Schanzer.

Recruiting
Registry status
NA
Development phase
600
Enrollment target
1
Study location

NCT02050113 is a NA study of Ehlers-Danlos Syndrome and Marfan Syndrome that is actively recruiting participants, run by Andres Schanzer. The registered enrollment target is 600 participants, above the 452-participant average among 5 other Ehlers-Danlos Syndrome trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT02050113, a NA study of Ehlers-Danlos Syndrome and Marfan Syndrome, is actively recruiting participants, sponsored by Andres Schanzer.

RECRUITING
Registry status
NA
Development phase
600 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Interventions

  • DEVICE Custom Made Fenestrated or Branched Stent Graft

Study Locations (1)

Massachusetts

  • UMass Memorial Health Care - University Campus - Worcester

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2014-03
Est. Completion 2030-03
Phase NA

Sponsor

Andres Schanzer

1 total trials

What the Registry Record Tells You About NCT02050113

The ClinicalTrials.gov registry entry for NCT02050113 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 452-participant average among 5 other Ehlers-Danlos Syndrome trials with a reported enrollment target (33% higher). The listed sponsor is Andres Schanzer, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Ehlers-Danlos Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Custom Made Fenestrated or Branched Stent Graft is the first listed.

NCT02050113 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02050113 about?

NCT02050113 is a clinical study titled "Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices". The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysm...

What is the current status of trial NCT02050113?

This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2014-03. Estimated completion is 2030-03.

What conditions does trial NCT02050113 study?

This clinical trial studies the following conditions: Ehlers-Danlos Syndrome, Marfan Syndrome, Aortic Arch Aneurysm, Thoracoabdominal Aneurysms, Loeys-Dietz Syndrome.

What interventions are being tested in trial NCT02050113?

The interventions under investigation include: Custom Made Fenestrated or Branched Stent Graft (DEVICE).

Who is sponsoring clinical trial NCT02050113?

This trial is sponsored by Andres Schanzer, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02050113 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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