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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by be Medical
Sponsor:
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01499329
First received: October 11, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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
Peripheral Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System

Resource links provided by NLM:


Further study details as provided by be Medical:

Primary Outcome Measures:
  • Binary (≥ 50%) restenosis rate [ Time Frame: 12, 24 months ] [ Designated as safety issue: No ]
    assessed by duplex ultrasound at the target lesion without the need for repeat TLR after the index-procedure in surviving patients with preserved limbs


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient receiving stent therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with iliac occlusive disease TASC A, B, C and D lesions.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499329

Contacts
Contact: Jan De Letter, MD 003250 45.25.60 jan.deletter@azbrugge.be

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

No publications provided

Responsible Party: be Medical
ClinicalTrials.gov Identifier: NCT01499329     History of Changes
Other Study ID Numbers: BM-EAZY-05-002
Study First Received: October 11, 2011
Last Updated: May 13, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by be Medical:
Stent therapy

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

ClinicalTrials.gov processed this record on July 20, 2014