N/A N=26 Treatment

Zenith® Dissection Endovascular System

Aortic Dissection

Bottom Line

View on ClinicalTrials.gov: NCT02094300 ↗

Enrolled (actual)

Serious AEs

7.7%

Results posted

Sep 2015

Primary outcome: Primary: Number of Patients With Major Complications — 2; 4; 2; 3 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Zenith® Dissection Endovascular Graft (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cook Group Incorporated
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Major Complications	2; 4; 2; 3; 3	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02094300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.