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Vascular LesionsPhase 4NCT01305174

Iliac, Common and External (ICE) Artery Stent Trial

A Phase 4 study testing PROTEGE GPS stent vs. VISI-PRO stent in people with Vascular Lesions, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Vascular Lesions
What is being tested?
PROTEGE GPS stent vs. VISI-PRO stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
1 siteGermany
Study dates
Oct 2010to Jul 2014
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 21 years.
  • Patient must sign informed consent form.
  • Patient must agree to participate in the study and comply with follow-up requirements.
  • Clinically, all patients must be in Rutherford category 1 to 4.
  • Angiographic Inclusion Criteria:
  • Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries.
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  • Lesion segment starts at the aortic bifurcation and ends at the take off of the common femoral artery (Offset of the iliac circumflex artery beneath the ligamentum inguinale).
  • The length of the lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
  • The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound or (MR-) angiography.
  • Patency of ipsilateral profunda artery. Ipsi- or contralateral artery lesions of the leg can be treated prior to the treatment of the study lesion.
  • In cases of two or more stenotic regions within the segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered as single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion!
  • A tandem lesion that can be treated with one stent will be considered as one lesion.

Who cannot join

  • Patient is currently participating in another clinical trial
  • Pregnancy or pregnancy planned during study duration
  • Life expectancy less than 2 years
  • Co-morbidities preventing study participation
  • Severe coagulation disorders
  • Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
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  • Active gastric ulcer or gastrointestinal bleeding
  • Thrombotic occlusion of the target vessel within previous 4 weeks.
  • Treatment of target lesion with laser or atherectomy devices.
  • Dialysis dependency.
  • Manifest hyperthyreosis.
  • Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
  • Known heparin intolerance.
  • Known paclitaxel intolerance.
  • Angiographic:
  • Target lesion extends into the femoral artery.
  • Symptomatic untreated inflow lesion > 70% in ipsilateral iliac arteries. Pretreatment of iliac stenosis is possible.
  • Target Lesion is in aortic bifurcation and needs treatment with "kissing balloon technique"
  • Lesion in abdominal aorta that needs treatment.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medical Care Center Prof. Mathey, Prof. Schofer

    Hamburg, Free and Hanseatic City of Hamburg, 22527

Other trials in Germany

About this study

Official title: Balloon Expandable vs. Selfexpanding Stents to Treat Stenosis or Occlusions of Common and External Iliac Artery Disease

The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease.

Being tested
PROTEGE GPS stent vs. VISI-PRO stent
Keywords
Common Iliac Artery and External Iliac Artery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROTEGE GPS stent vs. VISI-PRO stentDevice

    Also called ev3, peripheral stents, iliac artery, PAOD

    Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease

Study groups in NCT01305174
Study groupRoleWhat they receive
Balloon expandable stent armActive comparatorFirst placement of the sheath and successful passage of a 0.018" or 0.035" guidewire via the sheath across the target lesion in the iliac arteries was required. Consecutively the balloon-expandable stent (Visi-Pro™, ev3 Endovascular, Inc., Plymouth, MN, USA), which was premounted on a balloon catheter, was deployed by inflation of the balloon. The nominal stent diameter had to approximate the reference vessel diameter of the target lesion. Postdilation was permitted
Receives: Device: PROTEGE GPS stent vs. VISI-PRO stent
Selfexpanding stent armActive comparatorFirst placement of the sheath and successful passage of a 0.018" or 0.035" guidewire via the sheath across the target lesion in the iliac arteries was required. Consecutively the the self-expanding stent (Protege™, ev3 Endovascular, Inc., Plymouth, MN, USA), which had to exceed in the nominal diameter the reference vessel diameter at least by 1 mm, was released. Postdilation was mandatory. The inflated postdilation-balloon should approximate the reference vessel diameter.
Receives: Device: PROTEGE GPS stent vs. VISI-PRO stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duplex-ultrasound determined recurrent restenosis after 12 month

    Duplex-ultrasound definition:

    = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV >3.4 per duplex ultrasound

    Measured: 12 month

Secondary outcomes (7)

  1. Clinical improvement of walking distance and improvement of at least 1 Rutherford category

    Clinical improvement of walking distance and improvement of at least 1 Rutherford category

    Measured: 12 and 24 month

  2. Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines)

    Measured: 6 and 12 month

  3. Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month

    TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation

    Measured: at 6 and 12 month

  4. Recurrent stenosis >= 70%within the stent at 6 and 12 month

    Measured: at 6 and 12 month

  5. Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month

    Measured: at 1, 6 and 12 month

  6. Primary angiographic success rate (<30% residual stenosis)

    Measured: Procedure

  7. Major adverse vascular events plus death rate

    Major adverse vascular events plus death rate

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionJul 2013
  4. Study completionJul 2014

Why it stopped: Delayed recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01305174
Sponsor's protocol ID
ICE 3.0
Status last verified
Sep 2016
First submitted
25 Feb 2011
Last updated
30 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Krankenberg H, Zeller T, Ingwersen M, Schmalstieg J, Gissler HM, Nikol S, Baumgartner I, Diehm N, Nickling E, Muller-Hulsbeck S, Schmiedel R, Torsello G, Hochholzer W, Stelzner C, Brechtel K, Ito W, Kickuth R, Blessing E, Thieme M, Nakonieczny J, Nolte T, Gareis R, Boden H, Sixt S. Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1694-1704. doi: 10.1016/j.jcin.2017.05.015.

    PubMed 28838480

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PROTEGE GPS stent vs. VISI-PRO stent in people with Vascular Lesions, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. at 1 site in Germany.

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 12 inclusion and 19 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: stopped early, as of the sponsor's last update on 30 Sep 2016. 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 Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Delayed recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duplex-ultrasound determined recurrent restenosis after 12 month (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01305174, which also lists 1 linked publication.

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 30 Sep 2016.

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