Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease (EAZY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499329
Recruitment Status : Unknown
Verified July 2015 by be Medical.
Recruitment status was:  Recruiting
First Posted : December 26, 2011
Last Update Posted : July 16, 2015
Information provided by (Responsible Party):
be Medical

Brief Summary:
The purpose of this study is to evaluate safety and performance of the balloon-expandable Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC) A, B, C and D iliac lesions.

Condition or disease
Peripheral Artery Disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System
Study Start Date : December 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Patient receiving stent therapy

Primary Outcome Measures :
  1. Binary (≥ 50%) restenosis rate [ Time Frame: 12, 24 months ]
    assessed by duplex ultrasound at the target lesion without the need for repeat TLR after the index-procedure in surviving patients with preserved limbs

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with iliac occlusive disease TASC A, B, C and D lesions.

Inclusion Criteria:

  1. Patient is older than 18 years
  2. Patient must sign a written informed consent form that is approved by the ethics committee prior to index-procedure
  3. Patient must be compliant with all follow-up visits
  4. Patient suffers from intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4 and 5)
  5. Patient's life expectancy is more than 2 years
  6. Patient has iliac atherosclerotic de novo lesion(s) type A, B, C & D according to TASC-II classification
  7. Target vessel diameter is between 5 and 9 mm
  8. Target lesion has a baseline diameter stenosis of more than 50%
  9. Patient has sufficient infra-inguinal run-off with at least a patent common femoral artery and deep femoral artery (both <50% stenosis)

Exclusion Criteria:

  1. Patient has a life expectancy of less than 2 years
  2. Patient is refusing to be compliant with all follow-up visits
  3. Patient suffers from acute limb ischemia, defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
  4. Patient is intolerant to anticoagulant or antiplatelet therapy such as aspirin, heparin, clopidogrel or ticlopidine drug therapy
  5. Patient has already been treated with a stent in the ipsilateral target vessel
  6. Patient suffered tissue loss in the target extremities, defined as Rutherford 6
  7. Patient is already enrolled in this or another investigational device study
  8. Patient had a coronary intervention within the last 60 days before enrolment into this study or there is a planned coronary intervention within 60 days of enrolment into this study
  9. Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure
  10. Any planned surgical intervention within 30 days of the index-procedure
  11. Patient has an abdominal aortic aneurysm that is likely to require repair within the next 2 years.
  12. Patient has no sufficient infra-inguinal run-off (>50% stenosis). Patient inclusion is only possible if revascularization (endovascular or surgical) is performed in the same procedure with a peroperative angiographic control yielding <30% stenosis.
  13. Target lesion is a restenotic lesion.
  14. Target lesion is adjacent an aneurysm.
  15. Target vessel perforation with documented contrast extravasation during index-procedure prior to stent placement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499329

Contact: Jan De Letter, MD 003250 45.25.60

AZ Sint Jan Bruges Recruiting
Bruges, Belgium
Sponsors and Collaborators
be Medical
Principal Investigator: Jan De Letter, MD AZ Sint Jan Bruges

Responsible Party: be Medical Identifier: NCT01499329     History of Changes
Other Study ID Numbers: BM-EAZY-05-002
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by be Medical:
Stent therapy

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases