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B-SAFER Technique for Aortic Dissection (B-SAFER Trial)
N/A
Recruiting
Research Sponsored by Eric Roselli, M. D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at hospital discharge or at 1 month
Awards & highlights
B-SAFER Trial Summary
This trial is testing a new technique for repairing the aortic arch in patients with Thoracic Aortic Pathologies. The study is designed to assess the safety and feasibility of the new technique.
Who is the study for?
This trial is for adults over 18 with a life expectancy of more than two years who need repair or replacement of the thoracic aorta due to conditions like aneurysms, dissections, or congenital diseases. Participants must be able to consent and not have device sensitivities, uncorrectable bleeding disorders, active infections that could affect surgery outcomes, involvement in other studies with investigational products within the last six months, medical issues affecting trial participation, pregnancy, or severe brain malperfusion.Check my eligibility
What is being tested?
The B-SAFER clinical trial tests a new hybrid surgical technique for repairing complex thoracic aortic pathologies. It's designed for patients requiring repair near the arch proximal to the innominate artery origin. This single-center study is prospective (looking forward in time), non-blind (patients and researchers know what treatment is given), and non-randomized (patients are not chosen by chance for different treatments).See study design
What are the potential side effects?
While specific side effects are not listed here as it's a surgical procedure rather than drug administration; potential risks may include typical surgical complications such as infection at the incision site, bleeding problems related to sensitivity to device materials used during surgery.
B-SAFER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a serious problem with the main artery in my chest.
Select...
I am 18 years old or older.
B-SAFER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at hospital discharge or at 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hospital discharge or at 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause mortality
Complete sealing of the aortic pathology
Paralysis, excluding paraparesis
+3 moreSecondary outcome measures
Aortic related death
Aortic rupture
Device crimping/kinking
+24 moreB-SAFER Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,027 Previous Clinical Trials
1,363,938 Total Patients Enrolled
Eric Roselli, M. D.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for a serious problem with the main artery in my chest.I cannot undergo major surgery that stops my blood circulation.I am not in a coma or have severe, untreatable brain damage.I have an infection that might affect my surgery's success.I have a bleeding disorder that cannot be corrected.I have not participated in another study or taken any experimental treatments in the last 6 months.I am 18 years old or older.You are expected to live for at least two years after the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
What is the primary purpose of this investigation?
"This study's primary endpoint will be measured over the course of one month and is focused on ascertaining graft/endograft component patency. Secondary assessments include determining individual rates of failed device-extension overlap patency, thrombosis in the device lumen, and pseudoaneurysm at treatment sites via CT imaging."
Answered by AI
Is this endeavor currently open to enrollment?
"According to the data on clinicaltrials.gov, this experiment is actively recruiting individuals. This trial was first made available for enrollment on March 25th 2021 and has since been updated as recently as April 13th 2022."
Answered by AI
How many participants are taking part in this clinical experiment?
"Affirmative. Clinicaltrials.gov has evidence that this clinical research commenced on March 25th 2021 and was recently revised in April of 2022. The recruitment process is looking to bring in 100 individuals from a single trial centre."
Answered by AI
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