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Zenith TX2® Post-market Approval Study

2014-07-24 14:14:53 | BioPortfolio

Summary

The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Descending Thoracic Aortic Aneurysm

Intervention

Zenith TX2® TAA Endovascular Graft

Location

Kaiser Permanente
San Francisco
California
United States
94115

Status

Recruiting

Source

Cook

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:14:53-0400

Clinical Trials [1679 Associated Clinical Trials listed on BioPortfolio]

TX2® Low Profile TAA Endovascular Graft

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascul...

Zenith® TX2® Low Profile TAA Endosvascular Graft

The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated fo...

Zenith TX2-Low-Profile (LP) Clinical Study

The Zenith TX2-LP Clinical Study is a small, early clinical experience trial approved by the German regulatory authority to study the safety and effectiveness of the Zenith TX2® TAA Low-P...

Endovascular Exclusion of Thoracic Aortic Aneurysms

The purpose of this study is to assess the role of ascending, arch or descending thoracic aortic aneurysm exclusion using a novel endovascular prosthesis in high risk surgical patients.

Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endov...

PubMed Articles [4596 Associated PubMed Articles listed on BioPortfolio]

Open vs Endovascular repair of descending thoracic aortic aneurysm disease: a systematic review and meta-analysis.

The purpose of this study was to determine whether thoracic endovascular aortic repair reduces death and morbidity compared with open surgical repair for descending thoracic aortic disease.

Descending aortic banding for re-rupture of retrograde aortic dissection after emergency thoracic endovascular aortic repair.

Conversion to open repair after thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection is rare, but inevitable. We present a case of an 86-year-old man with ruptured type B aor...

The Case of Successful Surgical Treatment of a Patient With Thoracic Endograft Infection in 5 Years After Thoracic Endovascular Aortic Repair.

We present here a case of successful staged treatment of a patient with para-aortic abscess that arose 5 years after thoracic endovascular aortic repair because of thoracic aortic aneurysm. After stab...

Preoperative Sarcopenia Portends Worse Outcomes after Descending Thoracic Aortic Aneurysm Repair.

Sarcopenia may be an indicator of frailty. We used total psoas area index (TPAI) to identify sarcopenia and evaluated the effect of preoperative TPAI on outcomes following descending thoracic aortic a...

Transapical access for thoracic endovascular aortic repair to elephant trunk completion.

The 2-stage elephant trunk procedure is widely used to treat extensive disease of the aortic arch and descending thoracic aorta. The 2nd stage of the procedure can be accomplished with both a standard...

Medical and Biotech [MESH] Definitions

An abnormal balloon- or sac-like dilatation in the wall of the THORACIC AORTA. This proximal descending portion of aorta gives rise to the visceral and the parietal branches above the aortic hiatus at the diaphragm.

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

The tearing or bursting of the wall along any portion of the AORTA, such as thoracic or abdominal. It may result from the rupture of an aneurysm or it may be due to TRAUMA.

Cardiovascular manifestations of SYPHILIS, an infection of TREPONEMA PALLIDUM. In the late stage of syphilis, sometimes 20-30 years after the initial infection, damages are often seen in the blood vessels including the AORTA and the AORTIC VALVE. Clinical signs include syphilitic aortitis, aortic insufficiency, or aortic ANEURYSM.

An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.

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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


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