Research

At CTVS we are dedicated to providing access to the most advanced, state-of-the-art surgical care for our patients and participating in the scientific advancement of surgical medicine with a commitment to excellence in medical care. We participate in clinical research studies that will provide access to the most advanced technologies and treatments for our patients. Below is a list of the studies that we are currently conducting at CTVS.

If you have any questions regarding research at CTVS, please contact the CTVS Research Department at CTVSResearch@ctvstexas.com.

Vascular Research Trials

  • Sponsor: Veryan Medical Ltd.
  • Principal Investigator: Dr. Foteh
  • Coordinator: Dana Acosta
  • Description: The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.
  • For more information, go to: https://www.clinicaltrials.gov/ct2/show/NCT04640597?term=Mimics&recrs=ab&draw=2&rank=4

TAMBE

  • Sponsor: W.L. Gore & Associates
  • Principal Investigator: Dr. Foteh
  • Coordinator: Emily Rowe
  • Description: Prospective, non-randomized, multicenter study with two independent arms:
    Primary Study Arm – TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
    Secondary Study Arm – TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.
  • For more information, go to: https://www.clinicaltrials.gov/ct2/show/NCT03728985?term=TAMBE&draw=1&rank=3

  • Sponsor: Bolton Medical
  • Principal Investigator: Dr. Turley
  • Coordinator: Bonnie Punske
  • Description: This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
  • For more information, go to: https://www.clinicaltrials.gov/ct2/show/NCT03033043?term=RelayPro&draw=2&rank=2

 

Cardiac Research Trials

  • Sponsor: Ancora Heart, Inc.
  • Principal Investigator: Dr. Kerendi
  • Coordinator: Donna Johnson, CCRC
  • Description: This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.
  • Length of Follow-up: 5 years
  • For more information, go to:  https://clinicaltrials.gov/ct2/show/record/NCT03560167?term=accucinch&draw=2&rank=3.

  • Sponsor: Medtronic
  • Principal Investigator: Dr. Kerendi
  • Coordinator: Marcedes Coffman
  • Description: Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation who are candidates for conventional mitral valve surgery.
  • Length of Follow-up: 5 years
  • For more information, go to:  https://clinicaltrials.gov/ct2/show/NCT03242642?term=APOLLO+TMVR&rank=1.

  • Sponsor: Abbott Medical Devices
  • Principal Investigator: Dr. Kerendi
  • Coordinator: Donna Johnson, CCRC
  • Description: Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device.
  • For more information, go to:  https://clinicaltrials.gov/ct2/show/record/NCT03433274?term=SUMMIT+Tendyne&draw=2&rank=1.

    • Sponsor: Bolton Medical
    • Principal Investigator: Dr. Turley
    • Coordinator: Bonnie Punske
    • Description: This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
    • For more information, go to:  https://www.clinicaltrials.gov/ct2/show/NCT03033043?term=RelayPro&draw=2&rank=2.

 

 

 

 

 

 

 

      • Sponsor: Abbott Medical Devices
      • Principal Investigator: Dr. Zidar
      • Coordinator: Donna Johnson, CCRC
      • Description: The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
      • For more information, go to: https://clinicaltrials.gov/ct2/show/record/NCT03904147?term=triluminate&draw=2&rank=2

 

Thoracic Research Trials

      • Sponsor: University of Texas Southwestern Medical Center
      • CTVS Investigator: Dr. Medbery
      • Description: Pre-randomized study to determine if stereotactic ablative radiation (SAbR) improves survival over sublobar resection (SR) in high risk operable Stage I NSCLC
      • For more information, go to: https://clinicaltrials.gov/ct2/show/NCT02468024?term=stable-mates&rank=1

      • Sponsor: National Cancer Institute (NCI)
      • CTVS Investigator: Dr. Medbery
      • Description: This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient’s tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
      • For more information, go to: https://clinicaltrials.gov/ct2/show/NCT02194738?term=alchemist&rank=1
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