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COMPLETED NA

Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

NCT01114724 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

Conditions Studied

Interventions

  • DEVICE Valiant Thoracic Stent Graft with the Captivia Delivery System

Study Locations (17)

Texas

  • Heart Hospital Medical Center — Dallas
  • Baylor — Houston
  • Memorial Hermann Heart and Vascular Institute — Houston
  • St. Luke's Episcopal Hospital — Houston

California

  • USC Keck School of Medicine — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • Harbor UCLA — Torrance

North Carolina

  • Novant Health Heart and Vascular Institute — Charlotte
  • Duke University Medical Center — Durham

District of Columbia

  • Washington Hospital D.C. — Washington D.C.

Florida

  • University of Florida — Gainesville

Illinois

  • Northwestern Memorial — Chicago

Michigan

  • University of Michigan — Ann Arbor

New York

  • New York Presbyterian Weill Cornell — New York

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2010-05
Est. Completion 2017-10
Phase NA

Sponsor

Medtronic Cardiovascular

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01114724

The ClinicalTrials.gov registry entry for NCT01114724 describes a study currently listed as completed. 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 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 Aortic Dissection appearing as the primary indexed condition, and to 1 intervention — of which Valiant Thoracic Stent Graft with the Captivia Delivery System 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: NCT01114724 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, North Carolina. 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 NCT01114724 about?

NCT01114724 is a clinical study titled "Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections". The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). Th...

What is the current status of trial NCT01114724?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2010-05. Estimated completion is 2017-10.

What conditions does trial NCT01114724 study?

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

What interventions are being tested in trial NCT01114724?

The interventions under investigation include: Valiant Thoracic Stent Graft with the Captivia Delivery System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01114724?

This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01114724 being conducted?

This trial has 17 study locations across California, District of Columbia, Florida, Illinois, Michigan. 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