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

Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium
    • Recruiting
    • AZ Sint Jan Bruges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient receiving stent therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: be Medical
• Investigators: Principal Investigator: Jan De Letter, MD, AZ Sint Jan Bruges

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Stent therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: BM-EAZY-05-002