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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

February 25, 2011
September 29, 2016
October 2010
July 2013   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01305174 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Lesions
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: 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
    Intervention: Device: PROTEGE GPS stent vs. VISI-PRO stent
  • 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.
    Intervention: Device: PROTEGE GPS stent vs. VISI-PRO stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
660
July 2014
July 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01305174
ICE 3.0
No
Undecided
Not Provided
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Not Provided
Principal Investigator: Hans Krankenberg, Dr. Medical Care Center Prof. Mathey, Prof. Schofer
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP