Iliac, Common and External (ICE) Artery Stent Trial

Phase 4

Terminated

• Conditions: Vascular Lesions
• Interventions: Device: PROTEGE GPS stent vs. VISI-PRO stent

• Registration Number: NCT01305174
• Lead Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Primary Completion: 2013-07
• Study Completion: 2014-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 660

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon expandable stent arm	PROTEGE GPS stent vs. VISI-PRO stent	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
Selfexpanding stent arm	PROTEGE GPS stent vs. VISI-PRO stent	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.

Primary Outcome Measures

Name	Time	Method
Duplex-ultrasound determined recurrent restenosis after 12 month	12 month	Duplex-ultrasound definition: = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV \>3.4 per duplex ultrasound

Secondary Outcome Measures

Name	Time	Method
Major adverse vascular events plus death rate	24 month	Major adverse vascular events plus death rate
Clinical improvement of walking distance and improvement of at least 1 Rutherford category	12 and 24 month	Clinical improvement of walking distance and improvement of at least 1 Rutherford category
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
Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month	at 6 and 12 month	TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation
Primary angiographic success rate (<30% residual stenosis)	Procedure
Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines)	6 and 12 month

Trial Locations

Locations (1)

Medical Care Center Prof. Mathey, Prof. Schofer; 🇩🇪 Hamburg, Germany