Clinical Trials Logo
  1. Home
  2. Abdominal Aortic Aneurysm
  3. NCT01326884
  4. Details
NCT01326884 Clinical Trial

Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

Abdominal Aortic Aneurysm Clinical Trial

— ZLP  

Official title:
ZLP Clinical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01326884
Other study ID # 10-004
Secondary ID
Status Completed
Phase N/A
First received March 21, 2011
Last updated March 11, 2013
Start date February 2011
Est. completion date November 2012

Study information
Verified date March 2013
Source Cook
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size

- Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

- Less than 20 years of age

- Inability or refusal to give informed consent

- Disease considerations that would compromise patient safety or study outcomes

- Unsuitable arterial anatomy

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• ZLP
ZLP Graft

Locations
Country Name City State
Japan Nara Medical University Nara
Japan Jikei University Hospital Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite rate of adverse clinical/device events During (day 1) and after implantation through 12 months Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04227054 - Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks N/A
Active, not recruiting NCT03687489 - Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System N/A
Active, not recruiting NCT03507413 - Metformin Therapy in Non-diabetic AAA Patients Phase 2/Phase 3
Not yet recruiting NCT05756283 - The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair N/A
Not yet recruiting NCT04089241 - Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair N/A
Active, not recruiting NCT02604303 - A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Completed NCT02224794 - LIFE Study: Least Invasive Fast-Track EVAR
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Terminated NCT01843335 - Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair N/A
Completed NCT02229006 - Sodium Fluoride Imaging of Abdominal Aortic Aneurysms N/A
Terminated NCT01425242 - Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension N/A
Completed NCT01118520 - AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) Phase 2
Completed NCT00746122 - Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair N/A
Completed NCT03952780 - Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Completed NCT00583414 - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients N/A
Recruiting NCT05864560 - Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Completed NCT01683084 - Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms Phase 4
Active, not recruiting NCT03180996 - Global Fenestrated Anaconda Clinical sTudy
Completed NCT02493296 - The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Completed NCT03320408 - Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers