Peripheral Artery DiseaseEAZYNCT01499329
Safety and Performance of the Zeus CC Stent for the Treatment of Iliac Occlusive Disease
An observational study of Peripheral Artery Disease, run by be Medical at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with iliac occlusive disease TASC A, B, C and D lesions.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peripheral Artery Disease
- Keywords
- Stent therapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving stent therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan De Letter, MD, Principal investigator, AZ Sint Jan Bruges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499329
- Sponsor's protocol ID
- BM-EAZY-05-002
- Acronym
- EAZY
- Status last verified
- Jul 2015
- First submitted
- 11 Oct 2011
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Iliac Artery Occlusions or Stenoses Using the Zeus CC Stent System
- ClinicalTrials.gov ID
- NCT01499329
- Acronym / sponsor ID
- EAZY / BM-EAZY-05-002
- Conditions
- Peripheral Artery Disease
- Keywords
- Stent therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving stent therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iliac occlusive disease TASC A, B, C and D lesions.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Binary (≥ 50%) restenosis rate
Time frame: 12, 24 months
assessed by duplex ultrasound at the target lesion without the need for repeat TLR after the index-procedure in surviving patients with preserved limbs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan De Letter, MD principal investigator
AZ Sint Jan Bruges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by be Medical at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan De Letter, MD (003250 45.25.60, jan.deletter@azbrugge.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary (≥ 50%) restenosis rate (time frame: 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.