Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

NCT04467671 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: IDE187035UH3HL148693
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Conditions

HLH - Hypoplastic Left Heart Syndrome; DORV; DILV - Double Inlet Left Ventricle; Mitral Atresia; Tricuspid Atresia; Unbalanced AV Canal; Single-ventricle; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Keywords

Fontan; TEVG; Tissue Engineered Vascular Graft

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability of TEVG

  Assessed through graft related complications as determined by serial echocardiogram

  2 years

• Safety and Tolerability of TEVG

  Assessed through graft related complications as determined by serial MRI

  2 years

• Safety and Tolerability of TEVG

  Assessed through adverse events

  2 years

Secondary Outcomes (3)

• Efficacy of TEVG

  2 years

• Efficacy of TEVG

  2 years

• Efficacy of TEVG

  2 years

Study Arms (1)

Tissue Engineered Vascular Grafts

EXPERIMENTAL

Combination Product: Tissue Engineered Vascular Grafts

Interventions

Tissue Engineered Vascular Grafts COMBINATION_PRODUCT

Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)

Tissue Engineered Vascular Grafts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
• Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.

You may not qualify if:

• Patients will be excluded from participation in the study if they meet any of the following criteria.
• Patient has an urgent/emergent operative status.
• Patient has acute renal failure or renal insufficiency in the opinion of the investigator
• Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
• Patient has a pacemaker.
• Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)
• Patient has abnormal venous drainage (interrupted inferior vena cava \[IVC\]).
• Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.
• Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.
• Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate).
• Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.
• Preoperative hemoglobin \<11.0 mg/dL at time of patient's pre-admission testing.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Gunze Limited: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 32238576 BACKGROUND

• 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.

  PMID: 29906242 BACKGROUND

• 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.

  PMID: 26925512 BACKGROUND

• 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.

  PMID: 25397868 BACKGROUND

• 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.

  PMID: 24866863 BACKGROUND

• 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.

  PMID: 20106404 BACKGROUND

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome; Tricuspid Atresia; Univentricular Heart; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Interventions

Blood Vessel Prosthesis

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Christopher Breuer, MD

  Nationwide Children's Hospital

  STUDY CHAIR

• Toshiharu Shinoka, MD/PhD

  Nationwide Children's Hospital

  STUDY CHAIR

• Mark Galantowicz, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Fichtner, BSN, RN

CONTACT

614-355-5764; samantha.fichtner@nationwidechildrens.org

Victoria Shay

CONTACT

victoria.shay@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 13, 2020
• Study Start: July 15, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Prior to study initiation, the US FDA will have a comprehensive description of the processes followed to assure the accuracy, reliability, integrity, availability, and authenticity of required records and signatures supporting the data reported in the CSR will be provided to the Agency for confirmation that it will support a regulatory filing for TEVG. Every 6 months throughout the study, data will be shared with RM Innovation Catalyst, with a final locked data set no later than six months prior to the end of the award. Data from our long-term follow up policy will be made available on an annual basis if requested by the RM Innovation Catalyst or the NIH.
• Access Criteria: De-identified data will be provided to RM Innovation Catalyst. A Clinical Study Report will be submitted to the US FDA following the International Conference on Harmonization E3 Guideline for Industry: Structure and Content of Clinical Study Reports. Summary results of the trial will be submitted to ClinicalTrial.gov within one year of the primary completion date (per regulation and NIH policy). Results of screening tests and subjects participation in the study and ongoing test results will be shared with their primary care physician and/or primary cardiologist if cardiac care is being provided outside of Nationwide Children's Hospital.

Locations

US (1)