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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Aptus Endograft and EndoStaple for the treatment of Aortic Aneurysm, Abdominal or Aorto Iliac Aneurysm

Research Study Title

The STAPLE-International Post-Market Registry

Purpose

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Aptus Endosystems

Duration

55 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  1. Patient ≥ 18 years old

  2. Patient has given written informed consent

  3. Patient has a life expectancy > 1 year

  4. Patient is willing to comply with follow-up evaluations

  5. Patient's AAA meets at least one of the following criteria:

  6. ≥ 4.5cm in diameter

  7. Increased in size by 0.5cm in last 6 months

  8. Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment

  9. Saccular aneurysm larger than 3cm in maximal diameter

  10. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm

  11. Patient has a proximal aortic neck length of at least 12mm

  12. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.

  13. Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm

Exclusion Criteria:

  1. Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results

  2. Patient has a symptomatic AAA

  3. Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm

  4. Patient has irregularly-shaped plaque that would inhibit sealing stent apposition

  5. Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site

  6. Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition

  7. Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)

  8. Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)

Site Locations (4)

Country State City Zip Facility and Contact
Germany Berlin German Heart Center
Dr. Burkhart Zipfel

Dr. Burkhart Zipfel
Principal Investigator
Germany Frankfurt Cardiovascular Center Frankfurt
Prof. Horst Sievert

Prof. Horst Sievert, MD
Principal Investigator
Greece Athens Hellenic Airforce Hospital
Dr. Theo Perdikides

Theo Perdikides, MD
Principal Investigator
Netherlands Nieuwegein 3430 St Antonious Hospital
Dr. Jean Paul de Vries

Dr. Jean Paul de Vries
Principal Investigator

Contact

Irene Kuhn
212.266.0126
E-mail:

NCT ID: NCT01276249

Date Last Changed: November 17, 2014

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