Iliac, Common and External (ICE) Artery Stent Trial

NCT01305174 | Terminated Phase 4

• 1 other identifier: ICE 3.0
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Lesions

Keywords

Common Iliac Artery and External Iliac Artery

Outcome Measures

Primary Outcomes (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

  12 month

Secondary Outcomes (7)

• 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)

  6 and 12 month

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

  at 6 and 12 month

• Recurrent stenosis >= 70%within the stent 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

  at 1, 6 and 12 month

Study Arms (2)

Balloon expandable stent arm

ACTIVE COMPARATOR

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

Selfexpanding stent arm

ACTIVE COMPARATOR

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

Interventions

PROTEGE GPS stent vs. VISI-PRO stent DEVICE

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

Also known as: ev3, peripheral stents, iliac artery, PAOD

Balloon expandable stent arm; Selfexpanding stent arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries.
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.: lead

Study Sites (1)

Medical Care Center Prof. Mathey, Prof. Schofer

Hamburg, Hamburg, 22527, Germany

Location

Related Publications (1)

• 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.

  PMID: 28838480 DERIVED

Related Links

• Study website in german

Study Officials

• Hans Krankenberg, Dr.

  Medical Care Center Prof. Mathey, Prof. Schofer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: October 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: September 30, 2016

Record last verified: 2016-09

Locations

DE (1)