NCT05399680

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

RADIANCY was an acute, multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study, whose primary objective 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.™ 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, at 12 investigational sites across Europe. These subjects were followed up to 30 days post-procedure.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	S.M.A.R.T. RADIANZ™ Vascular Stent System	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.
DEVICE	BRITE TIP RADIANZ™ Guiding Sheath	BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
DEVICE	SABERX RADIANZ™ PTA Balloon Catheter	SABERX RADIANZ™ is a catheter with a distal inflatable balloon.

Timeline

• Start date: 2022-06-29
• Primary completion: 2023-09-22
• Completion: 2023-11-13
• First posted: 2022-06-01
• Last updated: 2025-08-11
• Results posted: 2025-08-11

Locations

12 sites across 6 countries: Austria, Belgium, France, Italy, Spain, Switzerland

Regulatory

• FDA-regulated device study