Cardiovascular Diseases Clinical Trial
— TEVG-2Official title:
Prospective, Open-labeled, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of the Second-generation Tissue Engineered Vascular Graft as Vascular Conduits for Extracardiac Total Cavopulmonary Connection.
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | August 2027 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients will be eligible for inclusion in the study if they meet all of the following criteria. 1. Patient must be a candidate to undergo an extracardiac total cavopulmonary connection. 2. Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study. Exclusion Criteria: - Patients will be excluded from participation in the study if they meet any of the following criteria. 1. Patient has an urgent/emergent operative status. 2. Patient has acute renal failure or renal insufficiency in the opinion of the investigator 3. Patient requires a graft less than 12 mm or greater than 24 mm in diameter. 4. Patient has a pacemaker. 5. Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units) 6. Patient has abnormal venous drainage (interrupted inferior vena cava [IVC]). 7. Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible. 8. Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures. 9. Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate). 10. Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations. 11. Preoperative hemoglobin <11.0 mg/dL at time of patient's pre-admission testing. |
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Nationwide Children's Hospital | Gunze Limited, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States,
Drews JD, Pepper VK, Best CA, Szafron JM, Cheatham JP, Yates AR, Hor KN, Zbinden JC, Chang YC, Mirhaidari GJM, Ramachandra AB, Miyamoto S, Blum KM, Onwuka EA, Zakko J, Kelly J, Cheatham SL, King N, Reinhardt JW, Sugiura T, Miyachi H, Matsuzaki Y, Breuer J, Heuer ED, West TA, Shoji T, Berman D, Boe BA, Asnes J, Galantowicz M, Matsumura G, Hibino N, Marsden AL, Pober JS, Humphrey JD, Shinoka T, Breuer CK. Spontaneous reversal of stenosis in tissue-engineered vascular grafts. Sci Transl Med. 2020 Apr 1;12(537):eaax6919. doi: 10.1126/scitranslmed.aax6919. — View Citation
Hibino N, McGillicuddy E, Matsumura G, Ichihara Y, Naito Y, Breuer C, Shinoka T. Late-term results of tissue-engineered vascular grafts in humans. J Thorac Cardiovasc Surg. 2010 Feb;139(2):431-6, 436.e1-2. doi: 10.1016/j.jtcvs.2009.09.057. — View Citation
Kurobe H, Maxfield MW, Naito Y, Cleary M, Stacy MR, Solomon D, Rocco KA, Tara S, Lee AY, Sinusas AJ, Snyder EL, Shinoka T, Breuer CK. Comparison of a closed system to a standard open technique for preparing tissue-engineered vascular grafts. Tissue Eng Part C Methods. 2015 Jan;21(1):88-93. doi: 10.1089/ten.TEC.2014.0160. — View Citation
Kurobe H, Tara S, Maxfield MW, Rocco KA, Bagi PS, Yi T, Udelsman BV, Dean EW, Khosravi R, Powell HM, Shinoka T, Breuer CK. Comparison of the biological equivalence of two methods for isolating bone marrow mononuclear cells for fabricating tissue-engineered vascular grafts. Tissue Eng Part C Methods. 2015 Jun;21(6):597-604. doi: 10.1089/ten.TEC.2014.0442. Epub 2014 Dec 29. — View Citation
Lee YU, Mahler N, Best CA, Tara S, Sugiura T, Lee AY, Yi T, Hibino N, Shinoka T, Breuer C. Rational design of an improved tissue-engineered vascular graft: determining the optimal cell dose and incubation time. Regen Med. 2016 Mar;11(2):159-67. doi: 10.2217/rme.15.85. Epub 2016 Feb 29. — View Citation
Ruiz-Rosado JD, Lee YU, Mahler N, Yi T, Robledo-Avila F, Martinez-Saucedo D, Lee AY, Shoji T, Heuer E, Yates AR, Pober JS, Shinoka T, Partida-Sanchez S, Breuer CK. Angiotensin II receptor I blockade prevents stenosis of tissue engineered vascular grafts. FASEB J. 2018 Jun 15;32(12):fj201800458. doi: 10.1096/fj.201800458. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of TEVG | Assessed through graft related complications as determined by serial echocardiogram | 2 years | |
Primary | Safety and Tolerability of TEVG | Assessed through graft related complications as determined by serial MRI | 2 years | |
Primary | Safety and Tolerability of TEVG | Assessed through adverse events | 2 years | |
Secondary | Efficacy of TEVG | Evaluate graft performance based on MRI | 2 years | |
Secondary | Efficacy of TEVG | Measured graft volume(mL) as determined by MRI | 2 years | |
Secondary | Efficacy of TEVG | Measured graft length (mm) as determined by MRI | 2 years |
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