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

Peripheral Artery Disease Clinical Trial

— EAZY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01499329
• Other study ID #: BM-EAZY-05-002
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2011
• Last updated: July 15, 2015
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: be Medical
• Contact: Jan De Letter, MD
• Phone: 003250 45.25.60
• Email: jan.deletter[@]azbrugge.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Belgium	AZ Sint Jan Bruges	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
be Medical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No