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ACTIVE NOT RECRUITING NA

Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

NCT03728985 · View on ClinicalTrials.gov ↗

Study Summary

Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)

Interventions

  • DEVICE GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Study Locations (20)

California

  • Keck Medical Center of USC — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles
  • Kaiser Permanente San Francisco Medical Center — San Francisco
  • Stanford University — Stanford

Minnesota

  • Essentia Health — Duluth
  • Division of Vascular Surgery - Minneapolis Heart Institute — Minneapolis
  • Mayo Clinic - Rochester — Rochester

Florida

  • University of Florida - Gainesville — Gainesville
  • University of South Florida — Tampa

Alabama

  • University of Alabama at Birmingham — Birmingham

Arizona

  • Mayo Clinic Arizona — Scottsdale

District of Columbia

  • MedStar Health Research Institute - MedStar Washington Hospital — Washington D.C.

Georgia

  • Emory University Hospital — Atlanta

Illinois

  • Northwestern University — Chicago

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2019-06-17
Est. Completion 2030-01
Phase NA

Sponsor

W.L.Gore & Associates

117 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03728985

The ClinicalTrials.gov registry entry for NCT03728985 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Thoracoabdominal Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention — of which GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03728985 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Minnesota, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03728985 about?

NCT03728985 is a clinical study titled "Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms". Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Sec...

What is the current status of trial NCT03728985?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 102 participants. The study started on 2019-06-17. Estimated completion is 2030-01.

What conditions does trial NCT03728985 study?

This clinical trial studies the following conditions: Thoracoabdominal Aortic Aneurysm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03728985?

The interventions under investigation include: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03728985?

This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03728985 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial