Zenith® Dissection Endovascular System

Aortic Dissection Clinical Trial

— STABLE I  

Official title:

Zenith® Dissection Endovascular System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02094300
• Other study ID #: 05-622
• Status: Active, not recruiting
• Phase: N/A
• First received: February 21, 2014
• Last updated: October 14, 2015
• Start date: December 2007
• Est. completion date: February 2017

Study information

• Verified date: October 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: February 2017
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Branch vessel obstruction/compromise

• Peri-aortic effusion/hematoma

• Resistant hypertension

• Persistent pain/symptoms

• Transaortic growth >5 mm within 3 months

• Transaortic diameter >40 mm.

Exclusion Criteria:

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

Device:
• Zenith® Dissection Endovascular Graft
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.

Locations

Country	Name	City	State
United States	Massachusetss General Hospital	Boston,	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	Thomas Jefferson University Hospital	Philadephia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes