Iliac, Common and External (ICE) Artery Stent Trial

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hamburg, Germany, 22527
        • Medical Care Center Prof. Mathey, Prof. Schofer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 21 years.
  2. Patient must sign informed consent form.
  3. Patient must agree to participate in the study and comply with follow-up requirements.
  4. Clinically, all patients must be in Rutherford category 1 to 4.

    Angiographic Inclusion Criteria:

  5. Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries.
  6. 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).
  7. The length of the lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
  8. The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound or (MR-) angiography.
  9. Patency of ipsilateral profunda artery. Ipsi- or contralateral artery lesions of the leg can be treated prior to the treatment of the study lesion.
  10. 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!
  11. A tandem lesion that can be treated with one stent will be considered as one lesion.

Exclusion Criteria:

  1. Patient is currently participating in another clinical trial
  2. Pregnancy or pregnancy planned during study duration
  3. Life expectancy less than 2 years
  4. Co-morbidities preventing study participation
  5. Severe coagulation disorders
  6. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
  7. Active gastric ulcer or gastrointestinal bleeding
  8. Thrombotic occlusion of the target vessel within previous 4 weeks.
  9. Treatment of target lesion with laser or atherectomy devices.
  10. Dialysis dependency.
  11. Manifest hyperthyreosis.
  12. Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
  13. Known heparin intolerance.
  14. Known paclitaxel intolerance.

    Angiographic:

  15. Target lesion extends into the femoral artery.
  16. Symptomatic untreated inflow lesion > 70% in ipsilateral iliac arteries. Pretreatment of iliac stenosis is possible.
  17. Target Lesion is in aortic bifurcation and needs treatment with "kissing balloon technique"
  18. Lesion in abdominal aorta that needs treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Balloon expandable stent arm
First 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
Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease
Other Names:
  • ev3
  • peripheral stents
  • iliac artery
  • PAOD
Active Comparator: Selfexpanding stent arm
First 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.
Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease
Other Names:
  • ev3
  • peripheral stents
  • iliac artery
  • PAOD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duplex-ultrasound determined recurrent restenosis after 12 month
Time Frame: 12 month

Duplex-ultrasound definition:

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

12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement of walking distance and improvement of at least 1 Rutherford category
Time Frame: 12 and 24 month
Clinical improvement of walking distance and improvement of at least 1 Rutherford category
12 and 24 month
Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines)
Time Frame: 6 and 12 month
6 and 12 month
Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month
Time Frame: at 6 and 12 month
TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation
at 6 and 12 month
Recurrent stenosis >= 70%within the stent at 6 and 12 month
Time Frame: at 6 and 12 month
at 6 and 12 month
Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month
Time Frame: at 1, 6 and 12 month
at 1, 6 and 12 month
Primary angiographic success rate (<30% residual stenosis)
Time Frame: Procedure
Procedure
Major adverse vascular events plus death rate
Time Frame: 24 month
Major adverse vascular events plus death rate
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hans Krankenberg, Dr., Medical Care Center Prof. Mathey, Prof. Schofer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (Estimate)

February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ICE 3.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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