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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2023-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PMCF Study for Peripheral Arteries Above the Knee (ATK)

NCT05312580

Peripheral Arterial Disease Femoropopliteal Stenosis Angiopathy, Peripheral

COMPLETED

Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

NCT00120406

Peripheral Vascular Diseases

COMPLETED NA

Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease

NCT04546477

Superficial Femoral Artery Disease Popliteal Artery Disease

ACTIVE_NOT_RECRUITING NA

Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

NCT01355406

Peripheral Artery Disease Peripheral Vascular Disease Vascular Disease +2 more

COMPLETED NA

PMCF Study for Peripheral Arteries Below the Knee (BTK)

NCT05444660

Peripheral Artery Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

BRITE TIP RADIANZ™ Guiding Sheath

Intervention Type 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.

SABERX RADIANZ™ PTA Balloon Catheter

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

SABERX RADIANZ™ PTA Balloon Catheter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

ALL patients must meet the following criteria prior to enrollment:

1. Age ≥ 18 years
2. For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure
3. Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5)
4. Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound
5. Eligibility for standard surgical repair, if necessary
6. A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion
7. The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure
8. 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.

10. 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

1. 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).
2. Previously deployed stent at the site of the target lesion
3. The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
4. Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
5. 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
6. The patient is receiving any form of dialysis.
7. The patient is receiving any form of immunosuppressant therapy.
8. Planned amputation
9. Established vasospastic disease
10. Glomerular filtration rate (GFR) \< 30 mL/min within 7 days prior to the index procedure
11. The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
12. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure
13. Bleeding diathesis
14. 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.
15. Known allergy or intolerance to Nitinol (nickel titanium)
16. Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines.
17. Known or suspected active infection at the time of the index procedure.
18. 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.
19. 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.

20. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
21. Noted perforation of the target vessel
22. Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation
23. 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
24. Presence of thrombus prior to crossing the lesion
25. Successful PTA treatment of a target lesion in the SFA/PPA (defined as \< 50% stenosis after PTA treatment)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No