Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatme… (NCT05399680) | Clinical Trial Compass
CompletedNot Applicable
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
The primary objective of this clinical investigation was 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
âś“. For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure
âś“. 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
âś“. Eligibility for standard surgical repair, if necessary
âś“. A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion
âś“. The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure
âś“. 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.
Exclusion criteria
âś•0. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following a transradial approach
âś•. 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).
What they're measuring
1
Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)
Timeframe: From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes first
2
Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)
Timeframe: From the time of insertion to the time of withdrawal of the SMART RADIANZ Vascular Stent System through the radial access artery, within the same day or 24 hours from the procedure start time
âś•. Previously deployed stent at the site of the target lesion
âś•. The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
âś•. Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
âś•. 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
âś•. The patient is receiving any form of dialysis.
âś•. The patient is receiving any form of immunosuppressant therapy.