The Boston Scientific ENOVUS Trial

2014-08-27 03:47:57 | BioPortfolio


A prospective, actively controlled, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA (Treatment Group) as compared to patients treated with conventional open surgery (Control Group).


The primary objectives of this study are to determine whether the Boston Scientific ENOVUS AAA Endograft is a safe and effective method of treating AAA’s in those patients considered to be suitable candidates for open surgical repair. The safety of the Boston Scientific ENOVUS AAA Endograft will be determined by comparing the rate of major morbidity in the Treatment Group against the rate of major morbidity in the Control Group within 30 days of the initial procedure. The efficacy of the Boston Scientific ENOVUS AAA Endograft will be determined by evaluating the proportion of patients in the Treatment Group that are free from AAA rupture and conversion to open surgical repair within 1 year of the initial procedure.

The secondary safety endpoints will be compared between the Treatment and Control Groups:Mortality rates at 30 days and 1 year, AAA related mortality at 30 days and 1 year. The secondary efficacy endpoints will be evaluated in the Treatment Group only and include: Technical success, enlargement of AAA, migration, significant endoleak, and loss of device integrity. Secondary Clinical Utility endpoints will be compared between the Treatment and Control groups and will include: blood loss, duration of procedure, ICU stay, length of hospital stay, and duration of anesthesia.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Abdominal Aortic Aneurysm


Boston Scientific ENOVUS AAA Endograft


University of Florida
United States




Boston Scientific Corporation

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:47:57-0400

Clinical Trials [1130 Associated Clinical Trials listed on BioPortfolio]

Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in dia...

Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneur...

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Dynamic Computed Tomography Angiography (CTA) Follow-up for EndoVascular Aortic Replacement (EVAR)

This pilot study aims to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in patients scheduled for standard endograft follow-up. The ...

Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome. the aim of this study is to assess the qualities of a predictive score on the occure...

PubMed Articles [6506 Associated PubMed Articles listed on BioPortfolio]

Rupture after previous endovascular aneurysm repair due to type IA endoleak: complete endograft preservation is feasible with proximal suturing, aortic neck banding and sac plication.

Rupture of an abdominal aortic aneurysm (AAA) after previous endovascular repair (EVAR) may require endograft explantation and replacement with a prosthetic surgical graft. Recent reports have suggest...

A custom-made Treovance® abdominal aortic aneurysm endograft to correct late failure of trombone technique with a tube endograft.

Unfavorable anatomy is one of the major limitations of endovascular aortic aneurysm repair (EVAR) with specifically, adverse proximal neck morphology excluding many patients from receiving the standar...

Rupture of an abdominal aortic aneurysm in a young man with Marfan Syndrome.

Abdominal aortic aneurysms are very rare in Marfan syndrome. We present a case with a young non-smoking and normotensive male with Marfan syndrome, who developed an infrarenal abdominal aortic aneurys...

Retinal microvascular signs and incidence of abdominal aortic aneurysm: The Atherosclerosis Risk in Communities Study.

To test the hypothesis that retinal microvascular abnormalities known to predict other cardiovascular diseases are associated prospectively with risk of abdominal aortic aneurysm. The rationale is tha...

Ten-year experience of the thoraco-abdominal aortic aneurysm treatment using a hybrid thoracic endovascular aortic repair.

The treatment of thoraco-abdominal aortic aneurysm continues to have a high mortality and paraplegia rate. In superaging societies, the methods of performing less invasive operations remain a major is...

Medical and Biotech [MESH] Definitions

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.

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.

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.

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.

Solitary lesions of bone that typically cause a bulging of the overlying cortex bearing some resemblance to the saccular protrusion of the aortic wall in aortic aneurysm, hence the name. (Dorland, 27th ed)

More From BioPortfolio on "The Boston Scientific ENOVUS Trial"

Quick Search


Relevant Topic

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Searches Linking to this Trial