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

NCT ID: NCT01499329

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient receiving stent therapy

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

be Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan De Letter, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint Jan Bruges

Locations

AZ Sint Jan Bruges

Bruges, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan De Letter, MD

Role: CONTACT

jan.deletter@azbrugge.be

003250 45.25.60

Other Identifiers

BM-EAZY-05-002

Identifier Type: -

Identifier Source: org_study_id