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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Primary Purpose

Abdominal Aortic Aneurysm

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Endologix Powerlink 34 mm stent graft cuff

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Powerlink, 34mm, Abdominal Aortic Aneurysm, EVAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years old or older
Informed consent understood and signed
Will comply with protocol follow-up requirements
Candidate for conventional open surgical repair
Aneurysm outer diameter is one or more of the following:
- greater than or equal to 4.0cm
- greater than or equal to 3.0cm (saccular aneurysm)
- greater than or equal to twice the normal aortic outer diameter
- rapidly growing (greater than or equal to 5mm over 6 months)
Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
Iliac artery internal diameter greater than or equal to 8 mm

Exclusion Criteria:

Life expectancy <2 years
Participating in another clinical study
Pregnant or lactating women
Acutely ruptured/leaking aneurysm
Traumatic vascular injury
Other medical or psychiatric problems
Contraindication to non-ionic contrast media or anticoagulants
Coagulopathy or bleeding disorder
Active systemic or localized groin infection
Indispensable inferior mesenteric artery
Connective tissue disease (e.g., Marfan's Syndrome)
Creatinine level >1.7 mg/dl
Renal transplant patient
Proximal attachment site >60º angle to the aneurysm body
Iliac arteries >90º angle
<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent]
Thrombus >30% at implantation site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Powerlink 34mm cuff stent graft

Outcomes

Primary Outcome Measures

Number of Participants With Proximal Type I Endoleak at Each Timepoint

Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).

Secondary Outcome Measures

Number of Participants With Successful Delivery and Deployment of the Device

Successful delivery and deployment of the device with no complication.

Number of Participants With Type III Endoleaks at Each Timepoint

Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.

Number of Participants With Stent Fracture at Each Timepoint

Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.

Number of Participants With Stent Graft Obstruction at Each Timepoint

Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.

Number of Participants With Migration at Each Timepoint

Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.

Number of Participants With Type II Endoleaks at Each Timepoint

Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.

Number of Participants With Aneurysm Diameter Change at Each Timepoint

Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.

Maximum Diameter Measurements

Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).

Aneurysm Volume Measurements

Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.

Full Information

NCT ID

NCT00706394

First Posted

May 2, 2008

Last Updated

October 22, 2021

Sponsor

Endologix

1. Study Identification

Unique Protocol Identification Number

NCT00706394

Brief Title

34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Official Title

Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 10, 2007 (Actual)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endologix

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study of anatomical fixation with a 34mm proximal extension

Detailed Description

The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm

Keywords

Powerlink, 34mm, Abdominal Aortic Aneurysm, EVAR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Powerlink 34mm cuff stent graft

Intervention Type

Device

Intervention Name(s)

Endologix Powerlink 34 mm stent graft cuff

Other Intervention Name(s)

Endologix Powerlink 34mm cuff [model 34-34-80L]

Intervention Description

Endovascular abdominal aortic aneurysm repair

Primary Outcome Measure Information:

Title

Number of Participants With Proximal Type I Endoleak at Each Timepoint

Description

Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).

Time Frame

Five years

Secondary Outcome Measure Information:

Title

Number of Participants With Successful Delivery and Deployment of the Device

Description

Successful delivery and deployment of the device with no complication.

Time Frame

1 Month

Title

Number of Participants With Type III Endoleaks at Each Timepoint

Description

Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.

Time Frame

5 Years

Title

Number of Participants With Stent Fracture at Each Timepoint

Description

Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.

Time Frame

5 Years

Title

Number of Participants With Stent Graft Obstruction at Each Timepoint

Description

Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.

Time Frame

5 Years

Title

Number of Participants With Migration at Each Timepoint

Description

Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.

Time Frame

5 Years

Title

Number of Participants With Type II Endoleaks at Each Timepoint

Description

Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.

Time Frame

5 Years

Title

Number of Participants With Aneurysm Diameter Change at Each Timepoint

Description

Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.

Time Frame

5 Years

Title

Maximum Diameter Measurements

Description

Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).

Time Frame

5 Years

Title

Aneurysm Volume Measurements

Description

Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.

Time Frame

5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old or older Informed consent understood and signed Will comply with protocol follow-up requirements Candidate for conventional open surgical repair Aneurysm outer diameter is one or more of the following: greater than or equal to 4.0cm greater than or equal to 3.0cm (saccular aneurysm) greater than or equal to twice the normal aortic outer diameter rapidly growing (greater than or equal to 5mm over 6 months) Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm Iliac artery internal diameter greater than or equal to 8 mm Exclusion Criteria: Life expectancy <2 years Participating in another clinical study Pregnant or lactating women Acutely ruptured/leaking aneurysm Traumatic vascular injury Other medical or psychiatric problems Contraindication to non-ionic contrast media or anticoagulants Coagulopathy or bleeding disorder Active systemic or localized groin infection Indispensable inferior mesenteric artery Connective tissue disease (e.g., Marfan's Syndrome) Creatinine level >1.7 mg/dl Renal transplant patient Proximal attachment site >60º angle to the aneurysm body Iliac arteries >90º angle <1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent] Thrombus >30% at implantation site

Overall Study Officials: