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Medical Device
AMDS Device for Aortic Dissection (PERSEVERE Trial)
N/A
Recruiting
Led By Wilson Szeto, MD
Research Sponsored by CryoLife, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age or ≤80 years of age (male or female) at time of surgery
Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
PERSEVERE Trial Summary
This trial is testing whether a new medical device is safe and effective for treating a certain type of heart problem.
Who is the study for?
This trial is for adults aged 18-80 with acute DeBakey type I aortic dissection diagnosed within the past two weeks, showing malperfusion symptoms. Excluded are those institutionalized by order, with signs of bowel infarction or bleeding, severe infections, CT angiogram ineligibility, bleeding disorders, certain heart and vascular conditions, pregnancy/breastfeeding status, unwillingness to follow the study protocol or accept blood transfusions.Check my eligibility
What is being tested?
The PERSEVERE trial is testing AMDS's safety and effectiveness in treating patients with acute DeBakey type I dissection through open surgical repair. It's a prospective (forward-looking), non-randomized study conducted across multiple centers.See study design
What are the potential side effects?
While specific side effects of AMDS are not listed here, similar interventions may include risks such as infection at the surgery site, inflammation around the area where AMDS is applied, allergic reactions to materials used in AMDS like nitinol or polytetrafluoroethylene.
PERSEVERE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I have poor blood flow to my brain, organs, or limbs.
PERSEVERE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint to Assess Change in Maximal True Lumen (TL) diameter
Primary Endpoint to Assess Incidence of Major Adverse Events
PERSEVERE Trial Design
1Treatment groups
Experimental Treatment
Group I: Acute DeBakey Type I DissectionExperimental Treatment1 Intervention
In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use.
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Who is running the clinical trial?
CryoLife, Inc.Lead Sponsor
17 Previous Clinical Trials
2,064 Total Patients Enrolled
1 Trials studying Aortic Dissection
202 Patients Enrolled for Aortic Dissection
Artivion Inc.Lead Sponsor
5 Previous Clinical Trials
1,244 Total Patients Enrolled
2 Trials studying Aortic Dissection
47 Patients Enrolled for Aortic Dissection
Syneos HealthOTHER
172 Previous Clinical Trials
68,361 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 80 years old.I have an infection caused by fungi.I have an abnormal connection between my aorta and another organ.I need surgery on my aorta or its branches as recommended by my doctor.I have poor blood flow in my heart's arteries.Your base deficit level is below a certain number.You are in a very critical condition and not expected to live for 24 hours, or you have been declared brain dead and your organs are being removed for donation.I have a bleeding disorder like hemophilia.You have had a device placed in your chest to treat a blood vessel problem.I was diagnosed with severe brain complications like coma before my dissection diagnosis.Your blood pressure is too low at the time of screening.My aortic arch aneurysm is larger than 50 mm.I am scheduled for a major surgery within 30 days after my dissection repair.I cannot get CT angiograms for follow-up.I have signs of severe bowel damage or bleeding in my stomach or intestines.My tear starts in the arch or beyond the left subclavian artery.I have poor blood flow to my brain, organs, or limbs.Your blood vessels are too twisted for the medical device to pass through safely.I do not have a medical condition that limits my life expectancy to less than 2 years.I have been diagnosed with Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome through genetic testing.You are allergic to nitinol or polytetrafluoroethylene.I needed CPR at the time of screening due to a severe heart condition.I refuse to receive blood transfusions under any circumstances.I have not had any surgery or interventional procedures within the last 30 days.I have a body-wide infection.My chest artery is enlarged, measuring more than 45 mm.I was diagnosed with a heart attack within the last 30 days.You have a severe allergic reaction to iodine-based contrast dye. If you have a milder allergy, you may still be eligible with special pre-treatment approved by the doctor.My doctor suspects I have dead bowel tissue based on tests and symptoms.My kidney function is very low (Stage 5).I was diagnosed with a type I aortic dissection less than 14 days ago.You have a lot of blood clots or hard deposits in a specific part of your heart, as seen in a special type of scan.
Research Study Groups:
This trial has the following groups:- Group 1: Acute DeBakey Type I Dissection
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.
How many facilities are currently hosting this experiment?
"This medical experiment is being conducted from 15 different sites, including Montefiore Einstein Medical in Bronx, New york; Emory University Medical Center in Atlanta, Georgia; and the University of Southern California in Los Angeles."
Answered by AI
Are there any current opportunities for individuals to take part in this experiment?
"According to clinicaltrials.gov, this medical study was first made available on May 27th 2022 and is actively seeking participants. The details of the trial were last modified in October 20th 2022."
Answered by AI
What are the prerequisites for entering into this medical study?
"The clinical trial is open to applicants aged 18-80 with aortic dissection. 93 participants are needed in total and eligibility criteria will be assessed during the screening process."
Answered by AI
Do participants of this medical trial have to meet a minimal age requirement?
"The age range for partaking in this trial is 18-80, with no exceptions."
Answered by AI
What is the maximum capacity of enrollees in this clinical trial?
"CryoLife, Inc. is looking to recruit 93 participants who meet the study criteria and will be carrying out the trial at various locations such as Montefiore Einstein Medical (Bronx, New york) and Emory University Medical Center (Atlanta, Georgia)."
Answered by AI
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