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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: Recruiting NA study of Ehlers-Danlos Syndrome and Marfan Syndrome, sponsored by Andres Schanzer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment success is a combination of technical success, and freedom at 12 months from the following: Type 1 and 3 Endoleaks, Stent migration of more than 10 mm, aortic aneurysm enlargement sac enlargement of more than 5 mm, aneurysm rupture and conversion to open repair.
Conditions Studied
Interventions
- DEVICE Custom Made Fenestrated or Branched Stent Graft
Study Locations (1)
Massachusetts
- UMass Memorial Health Care - University Campus - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2014-03 |
| Est. Completion | 2030-03 |
| Phase | NA |
What NCT02050113 shows while recruiting
NCT02050113 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 452-participant average among 5 other Ehlers-Danlos Syndrome trials with a reported enrollment target (33% higher).
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 a single indexed study location in 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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