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COMPLETED Phase 1

Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

NCT01328197 · View on ClinicalTrials.gov ↗

Study Summary

The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.

Conditions Studied

Interventions

  • DEVICE Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System

Study Locations (6)

North Carolina

  • Carolinas Sanger Heart and Vascular — Charlotte
  • East Carolina University — Greenville

Massachusetts

  • University of Massachusetts — Worcester

Michigan

  • Spectrum Health System — Grand Rapids

Pennsylvania

  • University of Pennsylvania — Philadelphia

Virginia

  • Sentara Heart Hospital — Norfolk

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-06
Est. Completion 2017-06
Phase Phase 1

Sponsor

Bolton Medical

36 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01328197

The ClinicalTrials.gov registry entry for NCT01328197 describes a study currently listed as completed. It is categorized as Phase 1, 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 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bolton Medical, which has 36 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 Abdominal Aortic Aneurysms appearing as the primary indexed condition, and to 1 intervention — of which Treovance Abdominal Aortic Stent-Graft with Navitel 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: NCT01328197 reports 6 study locations spanning 5 distinct geographic areas — top geographies include North Carolina, Massachusetts, Michigan. 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 NCT01328197 about?

NCT01328197 is a clinical study titled "Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms". The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of...

What is the current status of trial NCT01328197?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2017-06.

What conditions does trial NCT01328197 study?

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

What interventions are being tested in trial NCT01328197?

The interventions under investigation include: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01328197?

This trial is sponsored by Bolton Medical, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01328197 being conducted?

This trial has 6 study locations across Massachusetts, Michigan, North Carolina, Pennsylvania, Virginia. 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