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Iliac, Common and External (ICE) Artery Stent Trial

This study has been terminated.
(Delayed recruitment)
Sponsor:
Information provided by (Responsible Party):
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier:
NCT01305174
First received: February 25, 2011
Last updated: September 29, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Vascular Lesions
Device: PROTEGE GPS stent vs. VISI-PRO stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon Expandable vs. Selfexpanding Stents to Treat Stenosis or Occlusions of Common and External Iliac Artery Disease

Further study details as provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:

Primary Outcome Measures:
  • Duplex-ultrasound determined recurrent restenosis after 12 month [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

    Duplex-ultrasound definition:

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



Secondary Outcome Measures:
  • Clinical improvement of walking distance and improvement of at least 1 Rutherford category [ Time Frame: 12 and 24 month ] [ Designated as safety issue: No ]
    Clinical improvement of walking distance and improvement of at least 1 Rutherford category

  • 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 ] [ Designated as safety issue: No ]
  • Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month [ Time Frame: at 6 and 12 month ] [ Designated as safety issue: No ]
    TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation

  • Recurrent stenosis >= 70%within the stent at 6 and 12 month [ Time Frame: at 6 and 12 month ] [ Designated as safety issue: Yes ]
  • Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month [ Time Frame: at 1, 6 and 12 month ] [ Designated as safety issue: No ]
  • Primary angiographic success rate (<30% residual stenosis) [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Major adverse vascular events plus death rate [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    Major adverse vascular events plus death rate


Enrollment: 660
Study Start Date: October 2010
Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: PROTEGE GPS stent vs. VISI-PRO stent
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.
Device: PROTEGE GPS stent vs. VISI-PRO stent
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

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305174

Locations
Germany
Medical Care Center Prof. Mathey, Prof. Schofer
Hamburg, Germany, 22527
Sponsors and Collaborators
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Investigators
Principal Investigator: Hans Krankenberg, Dr. Medical Care Center Prof. Mathey, Prof. Schofer
  More Information

Additional Information:
Responsible Party: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier: NCT01305174     History of Changes
Other Study ID Numbers: ICE 3.0 
Study First Received: February 25, 2011
Last Updated: September 29, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:
Common Iliac Artery and External Iliac Artery

ClinicalTrials.gov processed this record on December 07, 2016