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

NCT01499329 | Unknown

• 1 other identifier: BM-EAZY-05-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Stent therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient receiving stent therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patient is older than 18 years
• Patient must sign a written informed consent form that is approved by the ethics committee prior to index-procedure
• Patient must be compliant with all follow-up visits
• Patient suffers from intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4 and 5)
• Patient's life expectancy is more than 2 years
• Patient has iliac atherosclerotic de novo lesion(s) type A, B, C \& D according to TASC-II classification
• Target vessel diameter is between 5 and 9 mm
• Target lesion has a baseline diameter stenosis of more than 50%
• Patient has sufficient infra-inguinal run-off with at least a patent common femoral artery and deep femoral artery (both \<50% stenosis)

You may not qualify if:

• Patient has a life expectancy of less than 2 years
• Patient is refusing to be compliant with all follow-up visits
• Patient suffers from acute limb ischemia, defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
• Patient is intolerant to anticoagulant or antiplatelet therapy such as aspirin, heparin, clopidogrel or ticlopidine drug therapy
• Patient has already been treated with a stent in the ipsilateral target vessel
• Patient suffered tissue loss in the target extremities, defined as Rutherford 6
• Patient is already enrolled in this or another investigational device study
• 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
• Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index-procedure
• Any planned surgical intervention within 30 days of the index-procedure
• Patient has an abdominal aortic aneurysm that is likely to require repair within the next 2 years.
• Target lesion is a restenotic lesion.
• Target lesion is adjacent an aneurysm.
• Target vessel perforation with documented contrast extravasation during index-procedure prior to stent placement.

Sponsors & Collaborators

• be Medical: lead

Study Sites (1)

AZ Sint Jan Bruges

Bruges, Belgium

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Jan De Letter, MD

  AZ Sint Jan Bruges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan De Letter, MD

CONTACT

003250 45.25.60; jan.deletter@azbrugge.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: December 26, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

BE (1)