The Heidelberg Iliac Trial for the Endovascular Treatment of Iliac Artery Lesions Using the Jaguar woven self-expanding Stent

Not Applicable

Conditions: I70.21

Registration Number: DRKS00030985

Lead Sponsor: Medizinische Universitätsklinik III

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 80

Inclusion Criteria

•Age = 18 years or minimum age as required by local regulations.
•Subject with documented diagnosis of peripheral arterial disease (PAD) in the iliac arteries.
•Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 0,5 cm including bilateral disease if both limbs are treated within 35 days.
•Positive diagnostic indication for PTA in addition to stent implantation in accordance with the Instructions for Use (IFU) of the Jaguar stent.
•Female subjects of childbearing potential must have a negative pregnancy test = 7 days before enrollment.
•Signed and dated Patient Informed Consent (PIC) form.
•Ability and willingness to comply with the clinical investigation plan.
•Life expectancy,in the investigator's opinion, of at least 12 months.

Exclusion Criteria

•High probability of non-adherence to CIP follow-up requirements.
•Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).
•Lesion within or adjacent to an aneurysm
•Plan for surgical procedure within 30 days after the study procedure (except for bilateral target limb treatment).
•Known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as:<br>Any re-intervention within the target lesion (s) due to symptoms or drop of ABI >30% or > 0.15 when compared to post-index procedure baseline ABI.<br>NOTE: TLRs which are performed on non-symptomatic subjects or based only on diagnostic imaging procedures do not meet the definition of clinically- driven TLR.

Secondary Outcome Measures