Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01328197 · ClinicalTrials.gov registry record · Phase 1
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
A Phase 1 study of Abdominal Aortic Aneurysms, sponsored by Bolton Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT01328197 is a Phase 1 study of Abdominal Aortic Aneurysms that has completed, run by Bolton Medical. The registered enrollment target is 30 participants, below the 197-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT01328197, a Phase 1 study of Abdominal Aortic Aneurysms, has completed, sponsored by Bolton Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-06 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 5 other Abdominal Aortic Aneurysms trials with a reported enrollment target (85% lower). The listed sponsor is Bolton Medical, which has 10 total studies on file at ClinicalTrials.gov.
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.
NCT01328197 reports 6 study locations spanning 5 distinct geographic areas - top geographies include North Carolina, Massachusetts, Michigan.
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.
What interventions are being tested in trial NCT01328197?
The interventions under investigation include: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System (DEVICE).
Who is sponsoring clinical trial NCT01328197?
This trial is sponsored by Bolton Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Abdominal Aortic Aneurysms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients
RECRUITING · NA
-
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
RECRUITING
-
Physician Modified Endovascular Grafts
RECRUITING · NA
-
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
COMPLETED · NA
-
Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study
COMPLETED · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.