Powerlink Bifurcated Stent Graft Long-Term Follow-up Study

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Endologix Powerlink Long-Term Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543270
• Other study ID #: TP00-005/CP04-001
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: November 2009

Study information

• Verified date: September 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endologix Infrarenal Bifurcated Stent Graft Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All surviving patients from the original study cohort who received the Powerlink device

• All surviving patients from the original study cohort who were assigned to the open surgical control arm

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Powerlink infrarenal bifurcated stent graft delivery system
Endovascular abdominal aortic aneurysm repair

Procedure:
• Open Surgery
Open surgical abdominal aortic aneurysm repair

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Mercy Hospital	Des Moines	Iowa
United States	Greenville Hospital System	Greenville	South Carolina
United States	Advanced Vascular Associates	Morristown	New Jersey
United States	Vascular and Transplant Specialists	Norfolk	Virginia
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	University of Illinois School of Medicine	Peoria	Illinois
United States	University Hospital of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	Heart Hospital of South Dakota	Sioux Falls	South Dakota
United States	SIU School of Medicine	Springfield	Illinois
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

References & Publications (4)

Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43. — View Citation

Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. — View Citation

Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16. — View Citation

Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No of Subjects with Major adverse events	Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke	At 1 Year
Primary	All Cause Mortality	No of deaths reported through 1 year	At 1 Year
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	30 Days
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	6 Months
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	Year 1
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	Year 2
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	Year 3
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	Year 4
Secondary	Stent Graft Performance	Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration	Year 5
Secondary	Clinical Utility Outcomes	Estimated anesthesia time, fluoroscopy time, procedure time	During the Procedure
Secondary	Clinical Utility Outcomes	Estimated blood loss (ml) and contrast volume (ml). Estimated blood loss records the approximate amount of blood that the patient lost during the surgery (ml) and contract volume is the volume of the contrast (ml) calculated during the procedure.	During the Procedure
Secondary	Clinical Utility Outcomes	Estimated ICU time	up to 1 week
Secondary	Clinical Utility Outcomes	Estimated Hospitalization Time	up to 1 week
Secondary	Aneurysm Morphology	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months	6 Months
Secondary	Aneurysm Morphology	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1	Year 1
Secondary	Aneurysm Morphology	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2	Year 2
Secondary	Aneurysm Morphology	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3	Year 3
Secondary	Aneurysm Morphology	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4	Year 4
Secondary	Aneurysm Morphology	Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5	Year 5