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

This study is currently recruiting participants.
Verified March 2013 by be Medical
Sponsor:
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01499329
First received: October 11, 2011
Last updated: March 20, 2013
Last verified: March 2013
  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
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: March 20, 2013
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 April 16, 2014