Iliac, Common and External (ICE) Artery Stent Trial

Vascular Lesions Clinical Trial

Official title:

Balloon Expandable vs. Selfexpanding Stents to Treat Stenosis or Occlusions of Common and External Iliac Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01305174
• Other study ID #: ICE 3.0
• Status: Terminated
• Phase: Phase 4
• First received: February 25, 2011
• Last updated: September 29, 2016
• Start date: October 2010
• Est. completion date: July 2014

Study information

• Verified date: September 2016
• Source: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 660
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Lesions

Intervention

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

Locations

Country	Name	City	State
Germany	Medical Care Center Prof. Mathey, Prof. Schofer	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Clinical improvement of walking distance and improvement of at least 1 Rutherford category	Clinical improvement of walking distance and improvement of at least 1 Rutherford category	12 and 24 month	No
Secondary	Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines)		6 and 12 month	No
Secondary	Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month	TLR = Target Lesion Revascularisation TVR = Target Vessel Revascularisation	at 6 and 12 month	No
Secondary	Recurrent stenosis >= 70%within the stent at 6 and 12 month		at 6 and 12 month	Yes
Secondary	Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month		at 1, 6 and 12 month	No
Secondary	Primary angiographic success rate (<30% residual stenosis)		Procedure	No
Secondary	Major adverse vascular events plus death rate	Major adverse vascular events plus death rate	24 month	Yes

External Links

•   Study website in german