The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.
The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Iliac stenting
Self-expanding stent
Michigan Vascular Research Center
Flint, Michigan, United States
New York Presbyterian Hospital, Columbia Campus
New York, New York, United States
The Number of Participants With Major Adverse Events (MAE)
Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry
Time frame: 30 days
Number of Participants With Acute Success
angiographic evidence of \< 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)
Time frame: from after stent placement to prior to hospital discharge (up to 3 days)
Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up- * Category 0: Asymptomatic, no hemodynamically significant occlusive disease; * Category 1: Mild claudication; * Category 2: Moderate claudication; * Category 3: Severe claudication; * Category 4: Ischemic rest pain; * Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia; * Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable
Time frame: From baseline up to 30-days
Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) \> 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI. An ABI ≥ 0.90 is considered normal.
Time frame: From baseline up to 30-days
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