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Clinical Trials for Aneurysm

General Purpose:

Aneurysms are a ballooning in the wall of an artery, and occur most often in the aorta. The aorta is the main artery that runs through the body, traveling from the heart through the chest and then down into the abdomen.

Aortic aneurysms often occur in the region of the chest or abdomen. However, aneurysms can also occur elsewhere in the body, such as the heart itself. In addition, aneurysms in the brain (also called cerebral aneurysms) commonly occur as well. Individuals may be born with cerebral aneurysms, or they can result from trauma, high blood pressure, infection, cancer, and cardiovascular disease.

Finding out that you have an aneurysm can be a frightening experience, for the simple fact that if an aneurysm bursts it can result in severe bleeding or even death. For example, if an aneurysm in the brain bursts it results in a stroke.

Fortunately, if aneurysms are detected early enough they can be successfully treated with the use of either medication or surgery. Additionally, researchers are hard at work investigating new methods of detecting and treating aneurysms, as well as looking at genetic patterns to better identify groups of individuals who may be at an increased risk of developing brain aneurysms.

What Will Aneurysm Clinical Trials Be Like?

The types of tests and assessments used in aneurysm clinical trials will ultimately depend on the specific nature of the study and what aspects of aneurysms are being investigated. Provided below is a list of frequent procedures and tests used to evaluate cardiovascular Clinical Trials for Aneurysmdisease in general, many of which may be incorporated for use in clinical trials:

  • Physical exam
  • Cardiac catheterization: a procedure during which a long, thin, and flexible tube (i.e., catheter) is inserted into a blood vessel in the arm, upper thigh, or neck and threaded through until it reaches your heart. This allows doctors to perform diagnostic tests and treatments, as well as to evaluate blockages in the blood vessels.
  • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans: these are non-invasive imaging procedures, similar to an x-ray, that allow doctors to take detailed pictures of your heart and blood vessels.
  • Coronary angiography: a procedure during which a dye is injected into a vein in your arm and then viewed using a special x-ray machine, CT scanner, or MRI machine. This allows doctors to view the insides of the arteries that provide blood to your heart. Angiography may also be used to evaluate other blood vessels throughout the body.
  • Abdominal ultrasound (to evaluate abdominal aortic aneurysms).
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Blood tests to look for chemical markers that indicate the presence of heart disease. Examples of these markers include troponin, CK-MB enzyme, myoglobin, hs-CRP, and BNP or NT-proBNP, pH, oxygen, and carbon dioxide. A sample of spinal fluid may also be analyzed.
  • Pain and quality of life assessments, as well as exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Aneurysm Clinical Trial Protocol:

Specific examples of clinical trials for individuals with aneurysms might include the following:

  • A study to investigate if supervised aerobic exercise among individuals with small abdominal aortic aneurysms (less than 50 millimeters in diameter) is safe and beneficial.
  • A clinical trial to compare a newly approved catheter-implanted device for treating aneurysms with standard treatment (using catheter-implanted platinum coils) to determine if the new device is as effective as standard treatment at preventing aneurysm recurrence.
  • A clinical trial to compare the use of two different blood pressure-lowering medications to determine if one is more effective than the other at a) decreasing the inflammation associated with small aortic aneurysms and b) shrink the diameter of the aneurysm.
  • A randomized trial that involves the use of a new medication compared to a placebo for use in preventing the development of cerebral vasospasm (decreased blood flow to and from the brain) following rupture of a brain aneurysm. A trial such as this (i.e., in which patients have the chance of receiving a placebo, or inactive treatment) is only done when there is no standard therapy available for the condition being studied. In this example, no standard therapy exists for the prevention of cerebral vasospasm. The following text provides additional information regarding randomized trials and placebos:

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the Clinical Trials for Aneurysminvestigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, such as the fourth clinical trial example provided above, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your medical history and a variety of clinical findings. Therefore, it is important to know asClinical Trials for Aneurysm many details as possible related to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • The specific location and size of your aneurysm.
  • Your prior history of heart disease and aneurysm.
  • Your prior history of treatment for heart disease (including any surgeries, procedures, and medications) and aneurysm.
  • Your current medications (including aspirin), vitamins, and dietary supplements.
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels.

Suggested Search Terms:

 “aortic aneurysm,” “abdominal aortic aneurysm,” “cerebral aneurysm,” “aneurysm repair,” “aneurysm medication,” “aneurysm surgery,” and “aneurysm surgery.”

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ZEnith AlPHa for AneurYsm Repair

Condition:   Aneurysm
Intervention:   Procedure: Zenith Alpha Abdominal stentgraft
Sponsors:   Philippe Cuypers;   Syntactx
Recruiting - verified May 2017

Cognition and Functional Connectivity After Elective Treatment of Brain Aneurysms

Condition:   Aneurysm
Interventions:   Procedure: Clipping;   Procedure: Coiling
Sponsors:   Medical University of Vienna;   Johannes Kepler University of Linz
Not yet recruiting - verified May 2017

Medina Embolization Device In Neurovascular Aneurysm Study

Condition:   Intracranial Aneurysm
Sponsors:   Medtronic Neurovascular Clinical Affairs;   Medtronic Bakken Research Center
Recruiting - verified December 2016

Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms

Condition:   Abdominal Aortic Aneurysm
Intervention:   Biological: MSC's or Plasmalyte
Sponsor:   VA Office of Research and Development
Recruiting - verified February 2017

Biocollection on the Familial Forms of Intracranial Aneurysm

Condition:   Intracranial Aneurysm
Intervention:   Genetic: Non-Interventional
Sponsor:   Nantes University Hospital
Enrolling by invitation - verified July 2016

Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

Condition:   Intracranial Aneurysm
Intervention:   Device: intracranial stent, flow diverter and coils
Sponsor:   Beijing Neurosurgical Institute
Recruiting - verified April 2017

Neuroform Atlas Stent for Intracranial Aneurysm Treatment

Condition:   Intracranial Aneurysm
Sponsor:   Stryker Neurovascular
Recruiting - verified April 2017

Matrix Aging and Aneurysm

Condition:   Aortic Aneurysm
Interventions:   Other: measurement of skin autofluorescence;   Other: skin biopsy collection
Sponsor:   CHU de Reims
Recruiting - verified December 2016

Coronary Artery Aneurysm Registry

Condition:   Coronary Artery Aneurysm
Sponsor:   St Carlos Hospital, Madrid, Spain
Active, not recruiting - verified October 2016

pCONus Treatment of Wide Neck Intracranial Aneurysms

Condition:   Intracranial Aneurysm
Intervention:   Device: implantation of the pCONus Bifurcation Aneurysm Implant
Sponsor:   Phenox GmbH
Recruiting - verified September 2016

Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System

Condition:   Iliac Aneurysm
Intervention:   Device: E-liac Stent Graft System
Sponsor:   JOTEC GmbH
Active, not recruiting - verified June 2016

EffectiveNess and SAfety of Small ANeurysm COiling Trial

Condition:   Aneurysm
Sponsors:   University of Virginia;   Stryker Neurovascular
Recruiting - verified August 2016

DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

Condition:   Cerebral Aneurysm
Intervention:   Device: Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils
Sponsors:   Centre hospitalier de l'Université de Montréal (CHUM);   DePuy Synthes;   Johnson & Johnson Medical Companies
Recruiting - verified March 2017

Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.

Condition:   Intracranial Aneurysm
Intervention:   Device: Endovascular treatment of intracranial aneurysm
Sponsor:   CHU de Reims
Active, not recruiting - verified December 2016

Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial

Condition:   Popliteal Artery Aneurysm
Interventions:   Procedure: Open repair of popliteal artery;   Procedure: Endovascular repair of popliteal artery
Sponsor:   Boston Medical Center
Terminated - verified January 2017

Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial

Condition:   Aneurysm
Interventions:   Drug: Doxycycline;   Drug: Placebo
Sponsors:   University of Maryland;   National Institute on Aging (NIA)
Active, not recruiting - verified March 2017

TARGET Intracranial Aneurysm Coiling Registry

Condition:   Intracranial Aneurysms
Intervention:   Device: Target 360°, 2D Coils, Nano Coils
Sponsors:   Mercy Health, Ohio;   Stryker Neurovascular
Recruiting - verified December 2016

Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

Condition:   Brain Aneurysm
Intervention:   Device: Surpass Flow Diverter
Sponsor:   Stryker Neurovascular
Active, not recruiting - verified May 2017

Framing Eighteen Coils in Cerebral Aneurysms Trial

Condition:   Cerebral Aneurysm
Interventions:   Procedure: Coil Embolization with larger Diameter Coils;   Procedure: Coil Embolization with Standard Diameter Coils
Sponsors:   Vanderbilt University;   Stryker Neurovascular
Recruiting - verified February 2017

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Condition:   Thoracoabdominal Aortic Aneurysm
Intervention:   Device: Zenith® t-Branch
Sponsors:   Lee, W. Anthony, M.D. FACS;   William Cook Australia
Recruiting - verified April 2017

TRUfill®'s Line in Intracranial aNeurysm Embolisation

Condition:   Aneurysms
Sponsor:   Codman & Shurtleff
Completed - verified July 2016

Study of the Penumbra Coil 400 System to Treat Aneurysm

Conditions:   Intracranial Aneurysms;   Peripheral Aneurysms
Intervention:   Device: PC 400 coils (Penumbra )
Sponsor:   Penumbra Inc.
Active, not recruiting - verified September 2016

Stenting in the Treatment of Aneurysm Trial

Condition:   Intracranial Aneurysm
Interventions:   Device: endovascular coiling with any type of currently approved coil (first or second generation);   Device: endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
Sponsors:   Centre hospitalier de l'Université de Montréal (CHUM);   CHRU de Brest (Brest University Hospital)
Recruiting - verified November 2016

Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

Condition:   Aneurysm
Intervention:   Device: GORE CTAG Device
Sponsor:   W.L.Gore & Associates
Active, not recruiting - verified April 2017

Pipeline for Uncoilable or Failed Aneurysms

Condition:   Intracranial Aneurysm
Intervention:   Device: Pipeline Embolization Device (PED)
Sponsor:   Medtronic Neurovascular Clinical Affairs
Completed - verified October 2016

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