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Thoraflex™ Hybrid IDE Study

NCT02724072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-05-16

No results posted yet for this study

Summary

The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta.

The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation.

Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta.

Patients will be followed for 3 years.

The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.

Conditions

  • Aortic Aneurysm
  • Aortic Dissection
  • Aortic Rupture

Interventions

DEVICE

Thoraflex™ Hybrid Device

Single-use medical device sterilized by ethylene oxide which is pre-loaded into a delivery system. The device comprises a gelatin sealed vascular graft combined with a stented graft.

Sponsors & Collaborators

  • Vascutek Ltd.

    collaborator INDUSTRY

  • Bolton Medical

    lead INDUSTRY

Principal Investigators

  • Joseph S Coselli · Baylor St. Luke's

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-22
Primary Completion
2019-06-24
Completion
2021-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02724072 on ClinicalTrials.gov