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Completed

NCT Number: NCT00706394

34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Study of anatomical fixation with a 34mm proximal extension

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Cardiac and Vascular Institute, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endologix Powerlink 34 mm stent graft cuff

Device

Endovascular abdominal aortic aneurysm repair

Other names: Endologix Powerlink 34mm cuff [model 34-34-80L]

Primary outcomes

  1. Number of Participants With Proximal Type I Endoleak at Each Timepoint

    Time frame: Five years

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

Secondary outcomes

  1. Number of Participants With Successful Delivery and Deployment of the Device

    Time frame: 1 Month

    Successful delivery and deployment of the device with no complication.

  2. Number of Participants With Type III Endoleaks at Each Timepoint

    Time frame: 5 Years

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

  3. Number of Participants With Stent Fracture at Each Timepoint

    Time frame: 5 Years

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

  4. Number of Participants With Stent Graft Obstruction at Each Timepoint

    Time frame: 5 Years

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

  5. Number of Participants With Migration at Each Timepoint

    Time frame: 5 Years

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

  6. Number of Participants With Type II Endoleaks at Each Timepoint

    Time frame: 5 Years

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

  7. Number of Participants With Aneurysm Diameter Change at Each Timepoint

    Time frame: 5 Years

    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.

  8. Maximum Diameter Measurements

    Time frame: 5 Years

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

  9. Aneurysm Volume Measurements

    Time frame: 5 Years

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

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2008
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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