NCT00526487

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

3.6 years

First QC Date

September 5, 2007

Last Update Submit

February 27, 2017

Conditions

Aortic Dissection Involving the Descending Thoracic Aorta

Keywords

Thoracic DissectionDissectionEndovascular

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is survival at 30 days

    30 days

Secondary Outcomes (1)

  • Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity

    12 months

Study Arms (1)

1

OTHER

Endovascular Repair

Device: Zenith® Dissection Endovascular SystemDevice: Endovascular Repair

Interventions

Zenith® Dissection Endovascular SystemDEVICE

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

1
Endovascular RepairDEVICE

Endovascular Repair

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Branch vessel obstruction/compromise
  • Peri-aortic effusion/hematoma
  • Resistant hypertension
  • Persistent pain/symptoms
  • Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

You may not qualify if:

  • Age less than 18 years
  • Frank rupture
  • Diagnosed or suspected congenital degenerative connective tissue disease
  • Systemic infection
  • Untreatable reaction to contrast
  • Surgical/endovascular AAA repair within 30 days
  • Previous placement of thoracic endovascular graft
  • Prior repair of descending thoracic aorta
  • Interventional/open procedures within 30 days
  • Onset of symptoms \> 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St. Vincent's Hospital Melbourne

Melbourne, VIC 3065, Australia

Location

St. Anne's Universtiy Hospital Brno

Brno, 656 91, Czechia

Location

CHRU de Lille

Lille, Cedex, 59037, France

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Heart Center Leipzig / Park Hospital

Leipzig, 04289, Germany

Location

Clinic of Internal Medicine, University Hospital Rostock

Rostock, 18057, Germany

Location

Hospital San Raffaele

Milan, 20129, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

  • Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.

    PMID: 31147139DERIVED

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Joseph Lombardi, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 10, 2007

Study Start

December 1, 2007

Primary Completion

July 1, 2011

Study Completion

September 1, 2016

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

CZ(1)DE(3)IT(2)FR(1)AU(1)