Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical investigation is to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.

Detailed Description
-----------------
RADIANCY is an acute, multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study, whose primary objective is to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ self-expanding stent in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via transradial artery access. The study enrolled 151 subjects, 22 of which were enrolled as roll-in subjects, across 12 investigational sites across Europe. These subjects will be followed up to 30 days post-procedure.

Official Title
-----------------
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: S.M.A.R.T. RADIANZ™ Vascular Stent System
* Device: BRITE TIP RADIANZ™ Guiding Sheath
* Device: SABERX RADIANZ™ PTA Balloon Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet ALL of the following inclusion criteria to be enrolled in the study: ALL patients must meet the following criteria prior to enrollment: Age ≥ 18 years For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5) Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound Eligibility for standard surgical repair, if necessary A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure Per Investigator assessment, the patient is willing and able to be followed up to 30 days post-procedure for evaluation and complete all required assessments per the study protocol. Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b (whichever is applicable) would be assessed via baseline angiography performed at the time of index procedure: The Investigator has assessed that the patient is a suitable candidate (i.e, meets all inclusion criteria and none of the exclusion criteria), for treatment of a lesion in the iliac, superficial femoral and/or proximal popliteal arteries via transradial approach and is eligible for conversion from a transradial to transfemoral approach, if it becomes necessary. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following a transradial approach Patients whose target lesion is in the iliac artery must meet these additional criteria prior to enrollment: 11a. A single de novo or restenotic lesion ≥ 50% stenosis in the common and/or external iliac artery 12a. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 100 mm, by visual assessment, within or across the common or external iliac arteries. The stenosis must be treatable with no more than two stents (while minimizing stent overlap) 13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment 14a. Angiographic evidence of a patent profunda or superficial femoral artery in the diseased (target) limb Patients whose target lesion is in the SFA and/or PPA must meet these additional criteria prior to enrollment: 11b. A single de novo or restenotic lesion ≥ 50% stenosis in the SFA and/or PPA 12b. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 150 mm, by visual assessment, within or across the SFA and/or PPA. The stenosis must be treatable with no more than two stents (while minimizing stent overlap) 13b. RVD ranging from 4.0 to 7.0 mm by visual assessment 14b. All lesions are to be located at least three centimeters proximal to the superior edge of the patella 15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with patency (<50% stenosis) of at least one of three vessels to the ankle or foot 16b. Adequate aortoiliac or common femoral inflow (defined as < 30% stenosis after PTA or stenting) prior to treatment of the target lesion (defined as < 30% stenosis after PTA or stenting) prior to treatment of the target lesion Exclusion Criteria: Patients will be excluded if ANY of the following exclusion criteria apply: The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or popliteal artery). Previously deployed stent at the site of the target lesion The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index procedure without complete resolution of the thrombus The patient is receiving any form of dialysis. The patient is receiving any form of immunosuppressant therapy. Planned amputation Established vasospastic disease Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the index procedure The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure Bleeding diathesis Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic medications including but not limited to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that cannot be medically managed. Known allergy or intolerance to Nitinol (nickel titanium) Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines. Known or suspected active infection at the time of the index procedure. Patient is currently participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or is planning to participate in such a study prior to their completion of this study. Patient has had a major surgical or interventional procedure unrelated to this study within 30 days prior to enrollment or is anticipated/planned to have such a procedure within 30 days after enrollment. Exclusion criteria 20 through 25 would be assessed via baseline angiography performed at the time of index procedure: Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device Noted perforation of the target vessel Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation Cases of chronic total occlusion/in-stent restenosis/severe calcification in which there is pre-determined inability to treat the target lesion with a single stent, or procedures pre-determined to require stent-in-stent placement to obtain patency Presence of thrombus prior to crossing the lesion Successful PTA treatment of a target lesion in the SFA/PPA (defined as < 50% stenosis after PTA treatment)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices | Device: S.M.A.R.T. RADIANZ™ Vascular Stent System<br>* The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.<br>Device: BRITE TIP RADIANZ™ Guiding Sheath<br>* BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.<br>Device: SABERX RADIANZ™ PTA Balloon Catheter<br>* SABERX RADIANZ™ is a catheter with a distal inflatable balloon.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome) | Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure-related complications (adverse events) associated with transradial artery access through time of hospital discharge. | From start of index procedure (time of initial puncture in the radial access artery) to the first occurrence of access site complication, time of discharge (  up to 1 week from date of index procedure) or study exit, whichever comes first | 
| Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome) | Technical success at the conclusion of the index procedure, defined as successful insertion of the S.M.A.R.T. RADIANZ™ Vascular Stent System into the peripheral vasculature through the radial artery, successful deployment of the study device (S.M.A.R.T.TM stent) at the intended location, and successful withdrawal of the delivery system without conversion from radial to femoral artery access. | From the time of insertion through the time of withdrawal of the SMART RADIANZ delivery system through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Deficiencies through 30 Days Post-Procedure | For each of the three (3) devices, peri-procedural (within 30 days post-index procedure) rate of device deficiencies | From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first | 
| Adverse Events through 30 Days Post-Procedure | Peri-procedural (within 30 days post-index procedure) rate of adverse events | From index procedure start (time of initial puncture in the radial access artery) to the first occurrence of adverse event, 30 days from date of index procedure or study exit, whichever comes first | 
| Death, Index Limb Amputation and TLR through 30 Days Post-Procedure | Peri-procedural (within 30 days post-index procedure) rate of death, index limb amputation and target lesion revascularization | From index procedure start (time of initial puncture in the radial access artery) to the first occurrence of death, index limb amputation or TLR, 30 days from date of index procedure or study exit, whichever comes first | 
| Procedural Complications through 30 Days Post-Procedure | Peri-procedural (within 30 days post-index procedure) rate of procedural complications | From index procedure start (time of initial puncture in the radial access artery) to the first occurrence of procedural complication, 30 days from date of index procedure or study exit, whichever comes first | 
| Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath | Technical success associated with use of the BRITE TIP RADIANZ™ Guiding Sheath, defined as successful insertion of the device into the peripheral vasculature through the radial artery (allowing for introduction of interventional and/or diagnostic devices) and successful withdrawal of the device. | From the time of insertion through the time of withdrawal of the BRITE TIP RADIANZ™ Guiding Sheath through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure. | 
| Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter | Procedural success associated with use of the SABERX RADIANZ™ PTA Balloon Catheter for pre-dilation and/or post-deployment stent dilatation (whenever applicable), defined as successful insertion of the device into the peripheral vasculature through the radial artery, successful inflation and deflation of the balloon, successful withdrawal of the device, and achievement of a final residual diameter stenosis of < 30% at the conclusion of the index procedure. | From the time of insertion through the time of withdrawal of the SABERX RADIANZ™ PTA Balloon Catheter through the radial access artery AND assessment of the final residual diameter stenosis, within the same day or 24 hours from the procedure start time |