Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection
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|ClinicalTrials.gov Identifier: NCT03033043|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Dissection Type B||Device: Relay Pro Stent-Graft||Not Applicable|
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
Subjects will be enrolled on a first come, first serve basis; however, no single investigational site may enroll more than 20% of the proposed sample size of up to 80 subjects. A subject is considered enrolled when arterial access is gained and an attempt is made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in mid-2016 and complete by the end of 2020.
All subjects enrolled, as defined above, will be included in the patient population for the primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the primary effectiveness analyses.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection|
|Actual Study Start Date :||December 14, 2017|
|Estimated Primary Completion Date :||May 17, 2019|
|Estimated Study Completion Date :||April 17, 2024|
Experimental: Experimental: Relay Pro
The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.
Device: Relay Pro Stent-Graft
Endovascular treatment of an aortic dissection
Other Name: Relay Pro Stent Graft System
- All-cause mortality post-procedure [ Time Frame: 30 days ]All-cause mortality 30 days post-procedure
- Technical Success at the time of the index procedure [ Time Frame: During deployment of the device ]Successful delivery and deployment of the device, including withdrawal of the delivery system;
- Treatment success through 1 month [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite ]
- Absence of Major adverse Event (MAE)
- Absence of relevant MAEs:
- New ischemia due to branch vessel compromise;
- Absence of unintentional rupture of the dissection septum;
- Dissection Treatment Success [ Time Frame: 1, 6, and 12 month follow-up visits, and annually through 5 years. ]• Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033043
|Contact: Lea Doyle||3523621021||LDoyle@BoltonMedical.com|
|Contact: Matthew Stark, Ph.Dfirstname.lastname@example.org|
|Principal Investigator:||Ed Y Woo, MD||MedStar Regional Vascular Program.|