Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
|ClinicalTrials.gov Identifier: NCT02009644|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2013
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm (AAA)||Device: Subjects who receive the Treovance stent-graft||Phase 2|
This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted.
The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S.
There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms:
- Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant
- Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days
Secondary objectives involve assessment of major device-related events and major morbidity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||AAA Device|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms|
|Study Start Date :||November 2013|
|Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||June 2021|
Subjects who receive the Treovance stent-graft
Device: Subjects who receive the Treovance stent-graft
Eligible subjects will be implanted with the Treovance Stent-Graft
Other Name: Treovance Abdominal Stent-Graft with Navitel Delivery System
- Primary Efficacy [ Time Frame: 12 months ]Successful aneurysm treatment which is a composite of the following: Technical success at the conclusion of the procedure; absence of aneurysm enlargement; absence of device-related complications (e.g., fracture, conversion to open surgical repair, etc.)
- Primary Safety [ Time Frame: 30 days ]The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)
- Secondary Safety Endpoint [ Time Frame: 30 days, 6 months, 12 months ]Secondary safety endpoints will include each individual rate for the adverse events included in the composite MAE at 30 days, 6 months, and annually.
- Secondary Efficacy Endpoint-- Secondary interventions [ Time Frame: 30 days, 6 months, annually ]The secondary efficacy endpoint includes the rate of additional procedures performed to correct the original implant
- Secondary Efficacy Endpoint -- Device-Related Complications [ Time Frame: 30 days, 6 months, and annually ]This endpoint includes the rate of complications associated with the device.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009644
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|Principal Investigator:||Matthew Eagleton, MD||Cleveland Clinic Foundaton|