Spontaneous reversal of stenosis in tissue-engineered vascular grafts.
Joseph D Drews, Victoria K Pepper, Cameron A Best...
https://pubmed.ncbi.nlm.nih.gov/32238576Actively Recruiting
Phase 2
All Genders
ID04467671
Prospective, Open-label, Single-arm Trial to Evaluate Safety and Efficacy of Second-Generation Tissue Engineered Vascular Grafts for Extracardiac Total Cavopulmonary Connection
Led by Nationwide Children's Hospital · Updated on 2025-06-27
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of second-generation tissue engineered vascular grafts (TEVGs) used as conduits for extracardiac total cavopulmonary connection (EC TCPC) in patients with single ventricle heart defects. This open-label, single-arm clinical trial focuses on monitoring adverse events, graft-related complications such as stenosis, aneurysmal dilation, thromboembolic or infectious events, and comparing complication rates with first-generation TEVGs. An interim analysis will assess early complications in the first six patients. Participants will undergo EC TCPC surgery using the second-generation TEVG as a conduit. After surgery, patients will be followed for at least two years with regular visits at Nationwide Children's Hospital. During this time, researchers will use serial imaging techniques including echocardiography and 4-dimensional MRI to monitor graft performance, growth, and remodeling. Throughout the study, patients will have their clinical status and graft function regularly evaluated through physical exams, imaging, and record keeping. Researchers will assess safety and tolerability over two years and track efficacy outcomes. The study includes careful monitoring for postoperative complications and requires informed consent from patients or their legal guardians before enrollment.
CONDITIONS
Brief Title
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
- Patient and/or legal guardian must voluntarily provide informed consent or assent for participation in the study.
You will not qualify if you...
- Patient has an urgent or emergent operative status.
- Patient has acute renal failure or renal insufficiency as judged by the investigator.
- Patient requires a graft smaller than 12 mm or larger than 24 mm in diameter.
- Patient has a pacemaker.
- Patient has pulmonary vascular resistance greater than 4 Wood's units.
- Patient has abnormal venous drainage such as interrupted inferior vena cava.
- Patient has significant atrio-ventricular valve regurgitation making them ineligible.
- Patient has another condition or medical problem that precludes compliance with study procedures.
- Patient is taking medications like bisphosphonates that could interfere with the graft.
- Patient or guardian is unable to comply with protocol evaluations.
- Preoperative hemoglobin is less than 11.0 mg/dL at pre-admission testing.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 day (surgery day)
Participants undergo extracardiac total cavopulmonary connection surgery using a tissue engineered vascular graft.
1 visit (in-person surgery)
Surgery and Immediate Post-operative Care
Duration - Up to 2 weeks or until discharge
Participants receive post-operative care and monitoring following a standardized clinical algorithm to evaluate graft function and complications.
Approximately 6 post-operative visits
Post-operative Follow-up
Duration - Up to 2 years
Participants have follow-up visits at Nationwide Children's Hospital for up to 2 years to monitor safety, tolerability, and efficacy of the graft using physical exams, echocardiography, and MRI.
Regular visits over 2 years with serial imaging and clinical assessments
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
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Research Team
S
Samantha Fichtner, BSN, RN
V
Victoria Shay
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Angiotensin II receptor I blockade prevents stenosis of tissue engineered vascular grafts.
Juan de Dios Ruiz-Rosado, Yong-Ung Lee, Nathan Mahler...
https://pubmed.ncbi.nlm.nih.gov/29906242Rational design of an improved tissue-engineered vascular graft: determining the optimal cell dose and incubation time.
Yong-Ung Lee, Nathan Mahler, Cameron A Best...
https://pubmed.ncbi.nlm.nih.gov/26925512Comparison of the biological equivalence of two methods for isolating bone marrow mononuclear cells for fabricating tissue-engineered vascular grafts.
Hirotsugu Kurobe, Shuhei Tara, Mark W Maxfield...
https://pubmed.ncbi.nlm.nih.gov/25397868Comparison of a closed system to a standard open technique for preparing tissue-engineered vascular grafts.
Hirotsugu Kurobe, Mark W Maxfield, Yuji Naito...
https://pubmed.ncbi.nlm.nih.gov/24866863Late-term results of tissue-engineered vascular grafts in humans.
Narutoshi Hibino, Edward McGillicuddy, Goki Matsumura...
https://pubmed.ncbi.nlm.nih.gov/20106404