Iliac, Common and External (ICE) Artery Stent Trial

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

Status and phase: Terminated; Phase 4

Conditions: Vascular Lesions

Treatments: Device: PROTEGE GPS stent vs. VISI-PRO stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01305174

ICE 3.0

Details and patient eligibility

About

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.

Enrollment: 660 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 2 patient groups

Balloon expandable stent arm

Active Comparator group

Description:

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

Treatment:

Device: PROTEGE GPS stent vs. VISI-PRO stent

Selfexpanding stent arm

Active Comparator group

Description:

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.

Treatment:

Device: PROTEGE GPS stent vs. VISI-PRO stent