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

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.1 site in 1 country660 target enrollmentOctober 2010

ConditionsVascular Lesions

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Vascular Lesions
Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Enrollment: 660
Locations: 1
Primary Endpoint: Duplex-ultrasound determined recurrent restenosis after 12 month
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

July 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Angiographic Inclusion Criteria:
•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Duplex-ultrasound determined recurrent restenosis after 12 month

Time Frame: 12 month

Duplex-ultrasound definition: = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV \>3.4 per duplex ultrasound

Secondary Outcomes

Major adverse vascular events plus death rate(24 month)
Clinical improvement of walking distance and improvement of at least 1 Rutherford category(12 and 24 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)
Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month(at 6 and 12 month)
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)