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

NCT05399680 | Completed Results DMC FDA Device

• 1 other identifier: P21-7701
• Study Type: interventional
• Target: 151
• Locations: 6 countries
• Sites: 12

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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 through time of hospital discharge.

  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

• 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.™ 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 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

Secondary Outcomes (6)

• Device Deficiencies Through 30 Days Post-Procedure

  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

  From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first

• Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure

  From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first

• Procedural Complications Through 30 Days Post-Procedure

  From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first

• Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath

  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.

Other Outcomes (9)

• Fluoroscopy Time

  From the start time to the end time of the period during which x-rays are produced, within the same day or 24 hours from the procedure start time

• Time to Achieve Hemostasis

  From the time of removal of the BRITE TIP RADIANZ Guiding Sheath to when hemostasis was first observed, within the same day or 24 hours from the procedure start time

• Time to Ambulation

  From the time of vascular closure to the time of ambulation, within the same day or 24 hours from the procedure start time, or study exit, whichever comes first

Study Arms (1)

Interventional

EXPERIMENTAL

Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices

Device: S.M.A.R.T. RADIANZ™ Vascular Stent System; Device: BRITE TIP RADIANZ™ Guiding Sheath; Device: SABERX RADIANZ™ PTA Balloon Catheter

Interventions

S.M.A.R.T. RADIANZ™ Vascular Stent System DEVICE

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.

Interventional

BRITE TIP RADIANZ™ Guiding Sheath DEVICE

BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.

Interventional

SABERX RADIANZ™ PTA Balloon Catheter DEVICE

SABERX RADIANZ™ is a catheter with a distal inflatable balloon.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• a. A single de novo or restenotic lesion ≥ 50% stenosis in the common and/or external iliac artery
• a. 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)
• a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment
• a. 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:
• b. A single de novo or restenotic lesion ≥ 50% stenosis in the SFA and/or PPA
• b. 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)
• b. RVD ranging from 4.0 to 7.0 mm by visual assessment
• b. All lesions are to be located at least three centimeters proximal to the superior edge of the patella
• b. 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
• b. 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
• 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

Sponsors & Collaborators

• Cordis US Corp.: lead
• Qserve: collaborator
• NAMSA: collaborator

Study Sites (12)

Univ Klinikum LKG Graz

Graz, Austria

Location

Klinikum Klagenfurt am Wörtherse

Klagenfurt, Austria

Location

Hanusch Krankenhaus

Vienna, Austria

Location

Univ.-Klinik für Innere Medizin II

Vienna, Austria

Location

A.Z. Sint-Blasius Hospital-Dendermonde

Dendermonde, Belgium

Location

Hospital Ambroise Pare

Boulogne-Billancourt, France

Location

Groupe Hôpital Paris St Joseph

Paris, France

Location

Clinique Rhena

Strasbourg, France

Location

Clinique Pasteur

Toulouse, France

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Hosp Univ. de Guadalajara

Guadalajara, Spain

Location

Kantonsspital Winterthur

Winterthur, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Limitations and Caveats

The cohort investigated excluded patients with various, pre-existing conditions and comorbidities, and so experienced clinicians should carefully consider in whom they prescribe intervention with the S.M.A.R.T. RADIANZ™ Vascular Stent System. Future studies could be undertaken to better ascertain the PAD patient cohorts that most likely stand to benefit from specifically from radial access and the S.M.A.R.T. RADIANZ™ Vascular Stent System compared to other contemporary treatment approaches.

Results Point of Contact

• Title: Rajesh Nathan
• Organization: Cordis

rajesh.nathan@cordis.com

(908) 528-3931

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: June 1, 2022
• Study Start: June 29, 2022
• Primary Completion: September 22, 2023
• Study Completion: November 13, 2023
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-02

Locations

IT (1); BE (1); CH (1); ES (1); AU (4); FR (4)