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Endovascular Graft
Custom-Made Endograft for Aortic Aneurysm (CARPE-CMD Trial)
N/A
Recruiting
Led By Andres Schanzer, MD
Research Sponsored by Andres Schanzer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
No systemic or local infection that may increase the risk of endovascular graft infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post procedure
Awards & highlights
CARPE-CMD Trial Summary
This trial is testing the safety and efficacy of custom-made devices and physician-modified devices to treat complex abdominal, thoracoabdominal, and aortic arch aneurysms in people who are at high risk for open surgical repair.
Who is the study for?
Adults with complex aortic aneurysms unsuitable for standard endovascular repair, at high risk for open surgery, or with specific connective tissue disorders like Marfan, Ehlers-Danlos, or Loeys-Dietz syndromes. Participants must not be pregnant/breastfeeding and able to follow up for five years.Check my eligibility
What is being tested?
The trial is testing custom-made stent grafts and modified FDA-approved devices on patients who can't use standard grafts due to their unique anatomy or those who cannot wait for traditional device manufacturing because of the severity of their condition.See study design
What are the potential side effects?
Potential side effects may include complications related to the implantation procedure such as infection, allergic reactions to materials in the stent graft (stainless steel, polyester), blood vessel damage during insertion, and issues from long-term wear.
CARPE-CMD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need immediate treatment and cannot wait for standard devices.
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I do not have any infections that could risk a graft infection.
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I am considered high risk for traditional surgery due to my condition or body's structure.
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I am 18 years old or older.
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My aortic aneurysm is growing quickly or needs repair due to symptoms.
CARPE-CMD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
Secondary outcome measures
Incidence of Major Adverse Events
CARPE-CMD Trial Design
1Treatment groups
Experimental Treatment
Group I: Endovascular repairExperimental Treatment1 Intervention
Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.
Find a Location
Who is running the clinical trial?
Andres SchanzerLead Sponsor
University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,210 Total Patients Enrolled
Andres Schanzer, MDPrincipal Investigator - University of Massachusetts, Worcester
UMass Memorial Medical Center-University Campus
New York University School Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The length of my neck's upper part is 25 mm or less.You are allergic to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol.You are not expected to live more than two years.The width of the proximal neck changes by more than 4 millimeters along its length.The end of my iliac artery is less than 10 mm long.The artery segment for stenting is less than 15 mm long and not forked.I need immediate treatment and cannot wait for standard devices.My doctor expects I have less than 2 years to live due to my cancer.My blood vessels are too narrow or twisted for certain medical procedures.The artery needing a stent is either less than 3 mm or more than 10 mm wide.I do not have any infections that could risk a graft infection.I am considered high risk for traditional surgery due to my condition or body's structure.I have a blood clotting disorder that cannot be corrected.My blood vessel has a clot or plaque at the site needing a seal.I am 18 years old or older.You had a severe allergic reaction to contrast dye that cannot be controlled with medication beforehand.You have religious or cultural reasons against receiving blood or blood products.I have an aortic or aortoiliac aneurysm that is 5.5 cm or larger.My aortic aneurysm is growing quickly or needs repair due to symptoms.I have unstable chest pain.My aneurysm's neck is angled over 60 degrees.I cannot keep at least one of my pelvic arteries open.The width of the iliac artery is less than 7.0 mm at any point where the doctor needs to access it.The width of the artery where it is attached to the same side of the body is more than 21 millimeters at the lower attachment point.
Research Study Groups:
This trial has the following groups:- Group 1: Endovascular repair
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 upper-limit of participants in this medical research experiment?
"Affirmative. According to the details on clinicaltrials.gov, this research is recruiting participants - its initial posting was March 1st 2014 and it most recently updated February 1st 2022. The study will accept 400 patients from a single facility."
Answered by AI
Does this clinical trial remain open for recruitment?
"Affirmative, current data hosted on clinicaltrials.gov indicates that this medical trial is in the process of recruiting individuals. First posted on March 1st 2014 and updated as recently as February 1st 2022, it aims to enrol 400 participants from one specific location."
Answered by AI
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