NCT02094300

Brief Summary

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with aortic dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

December 1, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 14, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 6, 2017

Status Verified

December 1, 2016

Enrollment Period

4.2 years

First QC Date

February 21, 2014

Results QC Date

August 13, 2015

Last Update Submit

December 12, 2016

Conditions

Aortic Dissection

Keywords

AortaThoracicAortic dissectionRuptureType BDeBakey type IIIEndovascular

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Major Complications

    Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.

    30 days

Study Arms (1)

Endovascular

EXPERIMENTAL
Device: Zenith® Dissection Endovascular Graft

Interventions

Zenith® Dissection Endovascular GraftDEVICE

Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.

Also known as: Endovascular graft, Stent-graft
Endovascular

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 \>5 mm within 3 months
  • Transaortic diameter \>40 mm.

You may not qualify if:

  • Age \<18 years;
  • Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
  • Pregnant, breast-feeding, or planning on becoming pregnant within 24 months;
  • Unwilling or unable to comply with the follow-up schedule
  • Inability or refusal to give informed consent
  • Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
  • Additional medical restrictions as specified in the Clinical Investigation Plan, or
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Florida

Gainesville, Florida, 32610, United States

Location

Massachusetss General Hospital

Boston, Massachusetts, 02114, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University Hospital

Philadephia, Pennsylvania, 19107, United States

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

Conditions

Aortic DissectionRupture

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic DiseasesWounds and Injuries

Results Point of Contact

Title
Scott Snyder, PhD, Director of Clinical Science and Biostatistics
Organization
Cook Research Incorporated
SSnyder@medinst.com
765-463-7537

Study Officials

  • Joseph Lombardi, MD

    The Cooper Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

February 21, 2014

First Posted

March 21, 2014

Study Start

December 1, 2007

Primary Completion

February 1, 2012

Study Completion

November 1, 2016

Last Updated

February 6, 2017

Results First Posted

September 14, 2015

Record last verified: 2016-12

Locations

US(5)