At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Symptomatic leg ischemia or ischemic ulcerations not exceeding foot digits (Rutherford/Becker Classification 2, 3, 4, or 5)
- ✓Palpable radial artery with diameter ≥2.5 mm confirmed by duplex ultrasound
- ✓For iliac lesions: single de novo or restenotic lesion ≥50% stenosis in common and/or external iliac artery, ≤100 mm length, treatable with ≤2 stents, RVD 4.0–9.0 mm, patent profunda or SFA
- ✕Any prior intervention to target vessel within 90 days (graft, stroke, cryoplasty, laser, atherectomy, aneurysm)
- ✕Previously deployed stent at target lesion site
- ✕Post-surgical stenosis or anastomotic suture treatments of target vessel
- ✕Requires general anesthesia for procedure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, and 1 other intervention for Peripheral Arterial Disease. Completed, enrolled 151 participants across 12 sites in 6 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ is a catheter with a distal inflatable balloon.