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Stent Graft System
Stent Graft for Aortic Aneurysm
N/A
Recruiting
Led By Geoffrey Answini, MD
Research Sponsored by The Christ Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Awards & highlights
Study Summary
This trial is studying a new device to treat thoracoabdominal aortic aneurysms. The primary goals are to assess safety and preliminary effectiveness of the device.
Who is the study for?
This trial is for adults over 18 with thoracoabdominal aortic aneurysms larger than 5.5 cm or growing quickly, at risk of rupture, or symptomatic. Candidates must have suitable anatomy for the stent graft and expect to live more than a year but can't be pregnant, breastfeeding, allergic to device materials like nitinol or polyester, have severe infections, kidney issues (creatinine >2.0 mg/dL), unmanageable blood clotting disorders, certain connective tissue diseases, or be unsuitable for X-ray imaging.Check my eligibility
What is being tested?
The Medtronic Valiant Thoracoabdominal Stent Graft System is being tested in patients with specific types of aortic aneurysms. The study aims to evaluate the safety and initial effectiveness of this device by monitoring technical and treatment success over time after implantation.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications related to the implant such as infection risks around the stent area; bleeding due to anticoagulation; allergic reactions; damage to surrounding organs or vessels; blockage within the stent; movement of the stent from its original position.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects free from major adverse events
Secondary outcome measures
Treatment Success at follow-up intervals
Trial Design
2Treatment groups
Experimental Treatment
Group I: Primary Study ArmExperimental Treatment1 Intervention
Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.
Group II: Expanded Selection ArmExperimental Treatment1 Intervention
Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.
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Who is running the clinical trial?
The Christ HospitalLead Sponsor
19 Previous Clinical Trials
1,378 Total Patients Enrolled
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,650 Total Patients Enrolled
Geoffrey Answini, MDPrincipal Investigator - The Christ Hospital
Christ Hospital
Temple University School Of Medicine (Medical School)
St Louis University School Of Medicine (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My anatomy prevents proper blood flow in my left subclavian artery.You have allergies to the materials used to make the medical devices, such as nickel-titanium, polyester, platinum-iridium, PTFE, platinum, gold, polyethylene, or stainless steel.I have an infection that could risk a graft infection.My body's structure allows for at least one open hypogastric artery.I have major issues with two of my body systems like heart, kidneys, liver, or muscles.My body size may prevent clear x-ray images or is too large for the equipment.The patient has a large aneurysm, or a history of aneurysm growth, or an aneurysm that is at risk of rupturing. The patient also must have certain blood vessel conditions and be at least 18 years old with a life expectancy of more than 1 year.I have chosen to undergo surgery as my treatment option.I can be treated with a standard, approved vascular device.My condition involves a contained rupture.I have a tear in the treated part of my aorta.I have a blood clotting disorder that cannot be corrected.I have had a major surgery not related to aneurysm treatment within the last 30 days.Your baseline creatinine level is higher than 2.0 mg/dL.You have a history of certain disorders that affect your connective tissues, like Marfan Syndrome or Ehlers-Danlos Syndrome.I am not willing to follow the required follow-up schedule.I cannot or do not want to give permission for treatment.I am allergic or react badly to blood thinners or dye used in imaging tests.I have unstable chest pain.I have had a ruptured aneurysm.I have had a stent placed in one of my body's main blood vessels.There is a blood clot or too much calcium build-up in the neck of the aneurysm.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Study Arm
- Group 2: Expanded Selection Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this experiment still open?
"Yes, according to information available on clinicialtrials.gov, this study is recruiting participants at the moment. It was initially shared on August 1st 2017 and had its last update on July 22nd 2019. A total of 15 patients are needed from one centre."
Answered by AI
What is the upper cap of participants in this research project?
"Affirmative. Clinicaltrials.gov shows that this trial is actively looking for participants, with the original post dating back to August 1st 2017 and last edited on July 22nd 2019. For now it is seeking 15 patients from a single medical centre."
Answered by AI
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